Hot Flashes, Menopause, Night Waking
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of BAY3427080 (NT-814), taken once a day, in the treatment of troublesome post-menopausal symptoms.
Detailed description
This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b study. The study will have a single-blind run-in period and will be adaptive with respect to the number of subjects recruited into each dose group. Four doses of BAY3427080 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4 weeks after the end of the treatment period. There will be a total of 8 visits whilst participating in the study. Subjects will record their hot flashes in an electronic diary during the screening period to establish eligibility and throughout the study after randomisation.
Interventions
BAY3427080 capsules
DRUGPlacebo
Placebo capsules
Sponsors
Nerre Therapeutics Ltd.
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Postmenopausal * Body mass index between 18 and 38 kg/m2, inclusive * Subject experiences moderate or severe hot flashes Key
Exclusion criteria
* Inability to comply with the use of prohibited and allowed medications as described in the protocol. * Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening. * Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation. * Any clinically significant abnormal laboratory test result(s) measured at Screening. * Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms. * Uncontrolled hypertension. * A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | From baseline to Week 4 | Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity. |
| Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | From baseline to Week 12 | Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity. |
| Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | From baseline to Week 4 | Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe). |
| Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | From baseline to Week 12 | Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity was graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | From baseline to Weeks 1, 2, 4, 8, 12 and 16 | Mean daily Hot Flushes score = Sum of (frequency x severity) filled in the diary during the last 7 days (with at least one available data in the evening and/or morning) divided by 7. Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe). |
| Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | Week 12 | The percent change from baseline at a visit Week 12 was calculated. Percent change = (change from baseline in mean daily frequency of moderate and severe hot flushes from baseline to Week 12 / Mean daily frequency of moderate and severe hot flushes at baseline) \* 100. A participant was considered as a responder with a reduction of ≥50% (or ≥80%) if the percent change was ≤-50 (or ≤-80). |
| Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | From baseline to Weeks 1, 2, 4, 8, 12 and 16 | Participants were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, participants recorded the total number of hot flushes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night. |
| Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | From baseline to Weeks 1, 2, 4, 8, 12 and 16 | Subjects were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, subjects recorded the total number of hot flashes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night. Night-time awakenings secondary to hot flashes corresponded to severe hot flash recorded on the morning diary, and all NTAs corresponded to the data recorded in the Total number of times you woke up last night? field from the eDiary recorded in the morning. Number of NTAs secondary to hot flushes could not be higher than the number of all NTAs. |
| Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | From baseline to Weeks 4, 8, 12 and 16 | The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI uses 19 individual items to generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each scored 0 (no difficulty) to 3 (severe difficulty). The sum of scores for these seven components yields one global score (range 0 to 21). Higher scores indicated worse sleep quality. |
| Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | From baseline to Weeks 4, 8, 12 and 16 | The ISI is a brief self-report questionnaire assessing the nature, severity, and impact of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Participants rated each item on a scale of 0 to 4, yielding a total score ranging from 0 to 28. The total score was calculated by adding the scores for all seven items. Higher scores indicated severe insomnia. |
| Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | The HFRDIS is a 10-item, self-report questionnaire assessing the impact of hot flushes on a woman's life during the past week. For each of the 10 items, participants rated how much hot flushes had interfered with that aspect of their life on a scale of 0 (not at all) to 10 (very much so). The total score was calculated by adding the scores for all 10 items. Higher scores indicated greater interference. |
| Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | From baseline to Weeks 4, 8, 12 and 16; | The MenQoL-I is a validated questionnaire used to measure condition-specific quality of life in menopausal women. It is composed of 32 items across four domains (physical, vasomotor, psychosocial and sexual). For each item, participants recorded whether they had experienced the problem in the past month, and if so, they rated how bothered they were by the problem on a scale of 0 (not at all bothered) to 6 (extremely bothered). The item scores were converted to a score ranging from 1 to 8. Domain scores are calculated by averaging the converted individual item scores (range 1-8) related to the respective domain. (Domains: Vasomotor - items 1 to 3, Psychosocial - items 4 to 10, Physical- items 11- to 26, Sexual - items 27 to 29). For a MENQOL total score the aggregated mean of the mean domain scores is calculated. Higher scores indicate greater bother. |
| Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | The BDI-II is a 21-item questionnaire assessing the intensity of depressive symptoms over the past 2 weeks. It is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Participants rated each item on a scale of 0 to 3 to give a total score ranging from 0 to 63, with a higher score suggesting more severe depressive symptoms. |
| Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | At Weeks 2, 4, 8 ,12 | Blood samples for analysis of plasma elinzanetant concentrations were collected at Weeks 2, 4, 8, and 12. A small number of participants had elinzanetant concentrations below the LOQ for the assay (1.5 ng/mL) at two or more visits (three participants in each of the 40 mg, 120 mg, and 160 mg groups, four in 80 mg group), indicating that these subjects were non compliant with treatment. |
| Nature and Severity of Adverse Events | Up to Week 16 | A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment. Safety Analysis Set. |
| Withdrawals Due to an Adverse Event | Up to Week 16 | A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment. |
| Number of Subjects Used Concomitant Medications | Up to Week 16 | A concomitant medication is defined as any medication used on or after date and time of first randomised treatment. All concomitant medications taken during the study were recorded in the eCRF. Any medication that was not specifically prohibited was allowed. (1) Antidiarrheals, intestinal antiinflammatory/antiinfective agents. |
| Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | From baseline to Weeks 2, 4, 8, 12 and 16 | Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician. |
| Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Normal ECG was decided by investigator. The findings are presented as Normal ECG. |
| Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal not clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal not clinically significant ECG. |
| Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal clinically significant ECG. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. In categories the number of subjects analyzed (N) for each week is mentioned for each reporting group respectively. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTc: QT corrected interval. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | At Weeks 2, 4, 8, 12 and 16 | All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTcF: QT interval with Fridericia's correction. |
| Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | From baseline to Weeks 2, 4, 8, 12 and 16 | Absolute QTcF values reported. |
| Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | From baseline to Weeks 2, 4, 8, 12 and 16 | Increase from Baseline overtime was reported. |
| Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Baseline to Weeks 4, 12 and 16 | The Columbia Suicide Severity Rating Scale (C-SSRS) is a rating scale created to evaluate suicidality in adults and children over the age of 12. It rates an individual's degree of suicidal ideation on a scale, ranging from wish to be dead to active suicidal ideation with specific plan and intent. The version used was the eC-SSRS, which is a subject-reported version of the scale. Shifts from baseline versus post-baseline to demonstrate changes in categories (cat) were reported using cat 1 (No Suicidal Ideation or Behaviour), cat 2 (Suicidal Ideation) and cat 3 (Suicidal Behaviour). |
| Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | From baseline to Weeks 2, 4, 12 and 16 | Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | From baseline to Weeks 2, 4, 8, 12 and 16 | Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | From baseline to Weeks 2, 4, 8, 12 and 16 | Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | From baseline to Weeks 2, 4, 8, 12 and 16 | Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | From baseline to Weeks 2, 4, 8, 12 and 16 | Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | From baseline to Weeks 2, 4, 8, 12 and 16 | Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | From baseline to Weeks 12 and 16 | Blood for assessment of bone turnover markers was collected and sent to the central laboratory for analysis. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. Urine pH was measured on a pH scale. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. |
| Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | From baseline to Weeks 1, 2, 8 and 16 | Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at high magnification (/HPF \[high-power field\]). |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF \[low-power field\]). |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. The evaluation of components in the urine samples such as bacteria, yeast, red blood cells (RBC), white blood cells (WBC), casts and crystals was performed by microscopy. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF \[low-power field\]) and high magnification (/HPF \[high-power field\]). Range and direction of scores microscopic identification of urine components: * Bacteria: none seen, 1+, 2+, 3+,4+, TNTC (too numerous to count). * Other urine components: none seen=normal; few, moderate, many, TNTC = abnormal. The higher the value, the higher the concentration of the component evaluated. |
| Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | From baseline to Weeks 2, 4, 12 and 16 | Urine for urinalysis was collected and sent to the central laboratory for analysis. Clinical relevance was judged by the investigator. Assessment was done using standard laboratory practice. For evaluation of the chemical properties of the urine sample test strips were used which have test pads of chemicals that change color when they come in contact with reagents. The degree of color change correlates with the amount of reagent present. Each color block represents a range of values. Range and direction of scores for reagents nitrite and urobilinogen: negative = normal; positive = abnormal. Range and direction of scores for all other reagents tested: negative = normal; trace, 1+, 2+, 3+ = abnormal, the higher the value, the higher the concentration of the reagent tested. |
| Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | From baseline to Weeks 1, 2, 8 and 16 | Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe). |
| Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | From baseline to Weeks 1, 2, 4, 8, 12 and 16 | Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity. |
| Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | From baseline to Weeks 1, 2, 4, 8, 12 and 16 | Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe). |
Countries
Canada, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted between 20 November 2018 (first participant, first visit) and 21 November 2019 (last participant, last visit) at 11 sites in the USA, nine sites in the UK, and five sites in Canada.
Pre-assignment details
A total of 760 participants were screened, of whom 199 completed screening and were randomised. Not meeting the eligibility criteria was the reason provided for all screening failures (561). A total of 47 participants were randomised to placebo and 152 participants to elinzanetant (BAY3427080).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received four placebo capsules orally once daily in the evening before bedtime. | 47 |
| 40 mg Elinzanetant (BAY3427080) Participants received one 40 mg elinzanetant capsule and 3 placebo capsules. | 31 |
| 80 mg Elinzanetant (BAY3427080) Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules. | 17 |
| 120 mg Elinzanetant (BAY3427080) Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule. | 52 |
| 160 mg Elinzanetant (BAY3427080) Participants received 4x40 mg elinzanetant capsules. | 52 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 | 0 | 5 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | 40 mg Elinzanetant (BAY3427080) | 80 mg Elinzanetant (BAY3427080) | 120 mg Elinzanetant (BAY3427080) | 160 mg Elinzanetant (BAY3427080) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 4.1 | 55.4 years STANDARD_DEVIATION 4 | 55.9 years STANDARD_DEVIATION 4.2 | 54.8 years STANDARD_DEVIATION 4.4 | 55.0 years STANDARD_DEVIATION 3.8 | 55.1 years STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 29 Participants | 16 Participants | 50 Participants | 46 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 5 Participants | 3 Participants | 13 Participants | 11 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 38 Participants | 24 Participants | 13 Participants | 37 Participants | 40 Participants | 152 Participants |
| Sex: Female, Male Female | 47 Participants | 31 Participants | 17 Participants | 52 Participants | 52 Participants | 199 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 31 | 0 / 17 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 18 / 47 | 13 / 31 | 14 / 17 | 23 / 52 | 23 / 52 |
| serious Total, serious adverse events | 2 / 47 | 0 / 31 | 1 / 17 | 1 / 52 | 1 / 52 |
Outcome results
Primary
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12
Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.
Time frame: From baseline to Week 12
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 11.82 Hot flushes per day | Standard Deviation 4.42 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -4.49 Hot flushes per day | Standard Deviation 4.29 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 12.13 Hot flushes per day | Standard Deviation 8.81 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -6.48 Hot flushes per day | Standard Deviation 7.82 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 14.55 Hot flushes per day | Standard Deviation 5.87 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -5.49 Hot flushes per day | Standard Deviation 5.31 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -7.91 Hot flushes per day | Standard Deviation 6.66 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 13.54 Hot flushes per day | Standard Deviation 7.17 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 12.92 Hot flushes per day | Standard Deviation 6.9 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -6.57 Hot flushes per day | Standard Deviation 5.83 |
Comparison: Change from Baseline to Week 12p-value: =0.209795% CI: [-4.28, -0.95]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.636995% CI: [-3.97, 2.44]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.011695% CI: [-5.22, -0.67]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.134695% CI: [-4.12, 0.56]Mixed-Effect Model Repeated Measures
Primary
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4
Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.
Time frame: From baseline to Week 4
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 11.82 Hot flushes per day | Standard Deviation 4.42 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -2.45 Hot flushes per day | Standard Deviation 3.65 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 12.13 Hot flushes per day | Standard Deviation 8.81 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -4.19 Hot flushes per day | Standard Deviation 5.78 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 14.55 Hot flushes per day | Standard Deviation 5.87 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -4.30 Hot flushes per day | Standard Deviation 6.45 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -6.76 Hot flushes per day | Standard Deviation 5.85 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 13.54 Hot flushes per day | Standard Deviation 7.17 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 12.92 Hot flushes per day | Standard Deviation 6.9 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -5.42 Hot flushes per day | Standard Deviation 5.36 |
Comparison: Change from Baseline to Week 4p-value: =0.194695% CI: [-3.83, 0.78]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.368295% CI: [-4.11, 1.53]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.000295% CI: [-5.94, -1.92]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.011595% CI: [-4.66, -0.6]Mixed-Effect Model Repeated Measures
Primary
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12
Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity was graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).
Time frame: From baseline to Week 12
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.2 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -0.41 Hot flushes per day | Standard Deviation 0.5 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 2.51 Hot flushes per day | Standard Deviation 0.26 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -0.53 Hot flushes per day | Standard Deviation 0.64 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 2.63 Hot flushes per day | Standard Deviation 0.24 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -0.26 Hot flushes per day | Standard Deviation 0.45 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -0.56 Hot flushes per day | Standard Deviation 0.68 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.24 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.26 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 | Week 12: Change from baseline | -0.73 Hot flushes per day | Standard Deviation 0.78 |
Comparison: Change from Baseline to Week 12p-value: =0.551195% CI: [-0.39, 0.21]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.382295% CI: [-0.2, 0.52]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.260695% CI: [-0.41, 0.11]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 12p-value: =0.047995% CI: [-0.53, 0]Mixed-Effect Model Repeated Measures
Primary
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4
Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).
Time frame: From baseline to Week 4
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.2 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -0.31 Hot flushes per day | Standard Deviation 0.41 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 2.51 Hot flushes per day | Standard Deviation 0.26 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -0.38 Hot flushes per day | Standard Deviation 0.54 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 2.63 Hot flushes per day | Standard Deviation 0.24 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -0.44 Hot flushes per day | Standard Deviation 0.56 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -0.51 Hot flushes per day | Standard Deviation 0.57 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.24 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.26 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 | Week 4: Change from baseline | -0.54 Hot flushes per day | Standard Deviation 0.67 |
Comparison: Change from Baseline to Week 4p-value: =0.703395% CI: [-0.3, 0.2]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.372495% CI: [-0.45, 0.17]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.089695% CI: [-0.41, 0.03]Mixed-Effect Model Repeated Measures
Comparison: Change from Baseline to Week 4p-value: =0.0995% CI: [-0.41, 0.03]Mixed-Effect Model Repeated Measures
Secondary
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide
Blood for assessment of bone turnover markers was collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Bone Specific Alkaline Phosphatase) | 12.17 ug/L | Standard Deviation 5.08 |
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Bone Specific Alkaline Phosphatase) | 0.48 ug/L | Standard Deviation 2.22 |
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Bone Specific Alkaline Phosphatase) | 0.86 ug/L | Standard Deviation 3.57 |
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Procollagen 1 N-Terminal Propeptide) | 58.1 ug/L | Standard Deviation 23.3 |
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide) | 5.0 ug/L | Standard Deviation 14.5 |
| Placebo | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide) | 3.6 ug/L | Standard Deviation 20.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide) | 0.5 ug/L | Standard Deviation 10.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -1.9 ug/L | Standard Deviation 9.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Bone Specific Alkaline Phosphatase) | 13.01 ug/L | Standard Deviation 5.09 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Bone Specific Alkaline Phosphatase) | 1.22 ug/L | Standard Deviation 7.58 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Procollagen 1 N-Terminal Propeptide) | 68.0 ug/L | Standard Deviation 24.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Bone Specific Alkaline Phosphatase) | 0.34 ug/L | Standard Deviation 4.24 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Procollagen 1 N-Terminal Propeptide) | 67.6 ug/L | Standard Deviation 15.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -5.7 ug/L | Standard Deviation 15.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Bone Specific Alkaline Phosphatase) | 13.94 ug/L | Standard Deviation 4.67 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Bone Specific Alkaline Phosphatase) | -1.18 ug/L | Standard Deviation 2.49 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Bone Specific Alkaline Phosphatase) | -0.68 ug/L | Standard Deviation 3.36 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -0.9 ug/L | Standard Deviation 19.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Procollagen 1 N-Terminal Propeptide) | 68.6 ug/L | Standard Deviation 29.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Bone Specific Alkaline Phosphatase) | -0.43 ug/L | Standard Deviation 2.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Bone Specific Alkaline Phosphatase) | 0.84 ug/L | Standard Deviation 3.55 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -2.5 ug/L | Standard Deviation 15.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -2.1 ug/L | Standard Deviation 13.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Bone Specific Alkaline Phosphatase) | 13.37 ug/L | Standard Deviation 4.69 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide) | -0.7 ug/L | Standard Deviation 10.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Bone Specific Alkaline Phosphatase) | 0.48 ug/L | Standard Deviation 2.98 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 12: Change from baseline (Bone Specific Alkaline Phosphatase) | -0.11 ug/L | Standard Deviation 2.73 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide) | 0.0 ug/L | Standard Deviation 11.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Procollagen 1 N-Terminal Propeptide) | 59.5 ug/L | Standard Deviation 23.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide | Baseline (Bone Specific Alkaline Phosphatase) | 13.36 ug/L | Standard Deviation 4.83 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 12: Change from baseline | -0.057 10^12*cells/L | Standard Deviation 0.277 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Baseline | 4.568 10^12*cells/L | Standard Deviation 0.392 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 16: Change from baseline | -0.060 10^12*cells/L | Standard Deviation 0.293 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 2: Change from baseline | -0.106 10^12*cells/L | Standard Deviation 0.262 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 4: Change from baseline | -0.094 10^12*cells/L | Standard Deviation 0.278 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 12: Change from baseline | -0.085 10^12*cells/L | Standard Deviation 0.256 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 4: Change from baseline | -0.083 10^12*cells/L | Standard Deviation 0.217 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 2: Change from baseline | -0.108 10^12*cells/L | Standard Deviation 0.218 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 16: Change from baseline | -0.023 10^12*cells/L | Standard Deviation 0.25 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Baseline | 4.537 10^12*cells/L | Standard Deviation 0.375 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 4: Change from baseline | 0.072 10^12*cells/L | Standard Deviation 0.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Baseline | 4.510 10^12*cells/L | Standard Deviation 0.365 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 2: Change from baseline | 0.007 10^12*cells/L | Standard Deviation 0.254 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 12: Change from baseline | 0.039 10^12*cells/L | Standard Deviation 0.273 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 16: Change from baseline | -0.033 10^12*cells/L | Standard Deviation 0.29 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 16: Change from baseline | -0.085 10^12*cells/L | Standard Deviation 0.254 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Baseline | 4.516 10^12*cells/L | Standard Deviation 0.429 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 12: Change from baseline | -0.057 10^12*cells/L | Standard Deviation 0.265 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 4: Change from baseline | -0.087 10^12*cells/L | Standard Deviation 0.203 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 2: Change from baseline | -0.095 10^12*cells/L | Standard Deviation 0.215 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 4: Change from baseline | -0.077 10^12*cells/L | Standard Deviation 0.229 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 12: Change from baseline | -0.057 10^12*cells/L | Standard Deviation 0.202 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Baseline | 4.563 10^12*cells/L | Standard Deviation 0.406 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 16: Change from baseline | -0.040 10^12*cells/L | Standard Deviation 0.24 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes | Week 2: Change from baseline | -0.090 10^12*cells/L | Standard Deviation 0.21 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 12: Change from baseline | -0.0106 Volume proportion | Standard Deviation 0.0294 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Baseline | 0.4230 Volume proportion | Standard Deviation 0.0347 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 16: Change from baseline | -0.0140 Volume proportion | Standard Deviation 0.0258 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 2: Change from baseline | -0.0121 Volume proportion | Standard Deviation 0.0261 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 4: Change from baseline | -0.0097 Volume proportion | Standard Deviation 0.0249 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 12: Change from baseline | -0.0036 Volume proportion | Standard Deviation 0.022 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 4: Change from baseline | -0.0060 Volume proportion | Standard Deviation 0.0194 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 2: Change from baseline | -0.0079 Volume proportion | Standard Deviation 0.022 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 16: Change from baseline | -0.0006 Volume proportion | Standard Deviation 0.025 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Baseline | 0.4184 Volume proportion | Standard Deviation 0.0303 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 4: Change from baseline | 0.0075 Volume proportion | Standard Deviation 0.0144 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Baseline | 0.4102 Volume proportion | Standard Deviation 0.0384 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 2: Change from baseline | 0.0016 Volume proportion | Standard Deviation 0.0211 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 12: Change from baseline | 0.0087 Volume proportion | Standard Deviation 0.0276 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 16: Change from baseline | 0.0015 Volume proportion | Standard Deviation 0.0244 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 16: Change from baseline | -0.0100 Volume proportion | Standard Deviation 0.0235 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Baseline | 0.4088 Volume proportion | Standard Deviation 0.0312 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 12: Change from baseline | -0.0083 Volume proportion | Standard Deviation 0.0258 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 4: Change from baseline | -0.0080 Volume proportion | Standard Deviation 0.0186 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 2: Change from baseline | -0.0079 Volume proportion | Standard Deviation 0.0195 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 4: Change from baseline | -0.0100 Volume proportion | Standard Deviation 0.0234 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 12: Change from baseline | -0.0115 Volume proportion | Standard Deviation 0.0231 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Baseline | 0.4182 Volume proportion | Standard Deviation 0.0346 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 16: Change from baseline | -0.0099 Volume proportion | Standard Deviation 0.0274 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit | Week 2: Change from baseline | -0.0138 Volume proportion | Standard Deviation 0.0199 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 12: Change from baseline | -1.22 fL | Standard Deviation 3.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Baseline | 92.74 fL | Standard Deviation 4.65 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 16: Change from baseline | -1.91 fL | Standard Deviation 2.99 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 2: Change from baseline | -0.56 fL | Standard Deviation 2.35 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 4: Change from baseline | -0.22 fL | Standard Deviation 2.53 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 12: Change from baseline | 0.98 fL | Standard Deviation 3.41 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 4: Change from baseline | 0.49 fL | Standard Deviation 2.31 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 2: Change from baseline | 0.51 fL | Standard Deviation 2.58 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 16: Change from baseline | 0.36 fL | Standard Deviation 3.41 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Baseline | 92.39 fL | Standard Deviation 4.51 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 4: Change from baseline | 0.27 fL | Standard Deviation 2.85 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Baseline | 90.92 fL | Standard Deviation 3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 2: Change from baseline | 0.24 fL | Standard Deviation 2.02 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 12: Change from baseline | 1.18 fL | Standard Deviation 2.72 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 16: Change from baseline | 1.05 fL | Standard Deviation 2.39 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 16: Change from baseline | -0.55 fL | Standard Deviation 4.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Baseline | 90.82 fL | Standard Deviation 5.25 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 12: Change from baseline | -0.77 fL | Standard Deviation 2.66 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 4: Change from baseline | -0.10 fL | Standard Deviation 1.92 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 2: Change from baseline | 0.10 fL | Standard Deviation 1.72 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 4: Change from baseline | -0.73 fL | Standard Deviation 4.48 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 12: Change from baseline | -1.47 fL | Standard Deviation 4.49 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Baseline | 91.88 fL | Standard Deviation 5.69 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 16: Change from baseline | -1.42 fL | Standard Deviation 5.06 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume | Week 2: Change from baseline | -1.29 fL | Standard Deviation 3.35 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 12: Change from baseline | -2.1 g/L | Standard Deviation 7.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Baseline | 138.4 g/L | Standard Deviation 10.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 16: Change from baseline | -1.9 g/L | Standard Deviation 8.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 2: Change from baseline | -3.0 g/L | Standard Deviation 7.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 4: Change from baseline | -2.7 g/L | Standard Deviation 8.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 12: Change from baseline | -2.5 g/L | Standard Deviation 7.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 4: Change from baseline | -2.6 g/L | Standard Deviation 6.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 2: Change from baseline | -3.0 g/L | Standard Deviation 6.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 16: Change from baseline | -0.7 g/L | Standard Deviation 6.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Baseline | 137.3 g/L | Standard Deviation 10 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 4: Change from baseline | 2.6 g/L | Standard Deviation 5.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Baseline | 136.4 g/L | Standard Deviation 11.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 2: Change from baseline | -0.2 g/L | Standard Deviation 7.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 12: Change from baseline | 0.8 g/L | Standard Deviation 7.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 16: Change from baseline | -1.7 g/L | Standard Deviation 8.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 16: Change from baseline | -2.6 g/L | Standard Deviation 6.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Baseline | 134.6 g/L | Standard Deviation 9.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 12: Change from baseline | -2.3 g/L | Standard Deviation 7.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 4: Change from baseline | -2.8 g/L | Standard Deviation 5.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 2: Change from baseline | -2.8 g/L | Standard Deviation 6.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 4: Change from baseline | -2.4 g/L | Standard Deviation 6.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 12: Change from baseline | -1.5 g/L | Standard Deviation 5.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Baseline | 135.6 g/L | Standard Deviation 11.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 16: Change from baseline | -1.1 g/L | Standard Deviation 6.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin | Week 2: Change from baseline | -2.5 g/L | Standard Deviation 5.4 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils/ Leukocytes) | 2.17 Percentage of total white blood cells | Standard Deviation 1.22 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes/ Leukocytes) | -0.32 Percentage of total white blood cells | Standard Deviation 6.82 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils/Leukocytes) | 1.10 Percentage of total white blood cells | Standard Deviation 6.92 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils/ Leukocytes) | 0.02 Percentage of total white blood cells | Standard Deviation 0.35 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes/Leukocytes) | 0.48 Percentage of total white blood cells | Standard Deviation 1.67 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils/ Leukocytes) | 0.16 Percentage of total white blood cells | Standard Deviation 0.87 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes/Leukocytes) | 7.41 Percentage of total white blood cells | Standard Deviation 1.76 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils/Leukocytes) | 0.30 Percentage of total white blood cells | Standard Deviation 9.57 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes/ Leukocytes) | -1.24 Percentage of total white blood cells | Standard Deviation 5.98 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes/Leukocytes) | 0.45 Percentage of total white blood cells | Standard Deviation 1.34 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils/ Leukocytes) | -0.13 Percentage of total white blood cells | Standard Deviation 0.84 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils/Leukocytes) | -0.64 Percentage of total white blood cells | Standard Deviation 6.11 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils/ Leukocytes) | 0.00 Percentage of total white blood cells | Standard Deviation 0.27 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes/ Leukocytes) | 0.27 Percentage of total white blood cells | Standard Deviation 5.12 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes/Leukocytes) | 0.24 Percentage of total white blood cells | Standard Deviation 1.31 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils/ Leukocytes) | 0.33 Percentage of total white blood cells | Standard Deviation 1.22 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils/ Leukocytes) | 0.02 Percentage of total white blood cells | Standard Deviation 0.22 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils/Leukocytes) | -0.48 Percentage of total white blood cells | Standard Deviation 7.92 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes/ Leukocytes) | -0.89 Percentage of total white blood cells | Standard Deviation 7.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes/Leukocytes) | 0.19 Percentage of total white blood cells | Standard Deviation 1.11 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Eosinophils/ Leukocytes) | 0.10 Percentage of total white blood cells | Standard Deviation 1.59 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils/Leukocytes) | 56.93 Percentage of total white blood cells | Standard Deviation 8.12 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils/ Leukocytes) | 0.03 Percentage of total white blood cells | Standard Deviation 0.28 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils/ Leukocytes) | 0.61 Percentage of total white blood cells | Standard Deviation 0.36 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes/ Leukocytes) | 32.87 Percentage of total white blood cells | Standard Deviation 7.02 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes/Leukocytes) | 7.71 Percentage of total white blood cells | Standard Deviation 2.07 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes/ Leukocytes) | 31.31 Percentage of total white blood cells | Standard Deviation 6.31 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils/ Leukocytes) | -0.04 Percentage of total white blood cells | Standard Deviation 0.21 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes/ Leukocytes) | -1.40 Percentage of total white blood cells | Standard Deviation 8.07 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes/ Leukocytes) | -0.54 Percentage of total white blood cells | Standard Deviation 5.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils/Leukocytes) | 2.00 Percentage of total white blood cells | Standard Deviation 9.27 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes/ Leukocytes) | -0.51 Percentage of total white blood cells | Standard Deviation 6.59 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes/ Leukocytes) | -1.25 Percentage of total white blood cells | Standard Deviation 5.12 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils/Leukocytes) | 1.54 Percentage of total white blood cells | Standard Deviation 5.78 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils/ Leukocytes) | 0.01 Percentage of total white blood cells | Standard Deviation 0.26 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils/Leukocytes) | 0.29 Percentage of total white blood cells | Standard Deviation 6.64 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils/ Leukocytes) | 0.05 Percentage of total white blood cells | Standard Deviation 0.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils/Leukocytes) | 57.37 Percentage of total white blood cells | Standard Deviation 7.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils/ Leukocytes) | 2.89 Percentage of total white blood cells | Standard Deviation 1.67 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils/ Leukocytes) | -0.01 Percentage of total white blood cells | Standard Deviation 0.19 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes/Leukocytes) | -0.50 Percentage of total white blood cells | Standard Deviation 1.75 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils/ Leukocytes) | 0.20 Percentage of total white blood cells | Standard Deviation 1.01 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils/ Leukocytes) | 0.72 Percentage of total white blood cells | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes/Leukocytes) | -0.19 Percentage of total white blood cells | Standard Deviation 1.64 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils/ Leukocytes) | -0.06 Percentage of total white blood cells | Standard Deviation 0.99 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils/Leukocytes) | 0.27 Percentage of total white blood cells | Standard Deviation 7.61 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes/Leukocytes) | -0.19 Percentage of total white blood cells | Standard Deviation 1.24 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils/ Leukocytes) | 0.41 Percentage of total white blood cells | Standard Deviation 1.49 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes/Leukocytes) | 0.05 Percentage of total white blood cells | Standard Deviation 1.83 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Eosinophils/ Leukocytes) | -0.15 Percentage of total white blood cells | Standard Deviation 1.18 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes/Leukocytes) | 8.18 Percentage of total white blood cells | Standard Deviation 1.62 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils/ Leukocytes) | 0.59 Percentage of total white blood cells | Standard Deviation 0.26 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils/ Leukocytes) | -0.01 Percentage of total white blood cells | Standard Deviation 0.18 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils/ Leukocytes) | -0.02 Percentage of total white blood cells | Standard Deviation 0.22 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils/ Leukocytes) | 0.03 Percentage of total white blood cells | Standard Deviation 0.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils/ Leukocytes) | 0.06 Percentage of total white blood cells | Standard Deviation 0.22 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils/ Leukocytes) | 2.66 Percentage of total white blood cells | Standard Deviation 1.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils/ Leukocytes) | -0.12 Percentage of total white blood cells | Standard Deviation 0.75 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils/ Leukocytes) | -0.15 Percentage of total white blood cells | Standard Deviation 1.14 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils/ Leukocytes) | 0.11 Percentage of total white blood cells | Standard Deviation 1.16 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Eosinophils/ Leukocytes) | 0.00 Percentage of total white blood cells | Standard Deviation 1.53 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes/ Leukocytes) | 28.71 Percentage of total white blood cells | Standard Deviation 7.07 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes/ Leukocytes) | -1.32 Percentage of total white blood cells | Standard Deviation 4.45 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes/ Leukocytes) | -0.89 Percentage of total white blood cells | Standard Deviation 3.68 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes/ Leukocytes) | 0.13 Percentage of total white blood cells | Standard Deviation 4.78 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes/ Leukocytes) | -0.75 Percentage of total white blood cells | Standard Deviation 4.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes/Leukocytes) | -0.24 Percentage of total white blood cells | Standard Deviation 2.01 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes/Leukocytes) | -0.29 Percentage of total white blood cells | Standard Deviation 1.71 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes/Leukocytes) | -0.67 Percentage of total white blood cells | Standard Deviation 1.27 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes/Leukocytes) | -0.48 Percentage of total white blood cells | Standard Deviation 1.45 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils/Leukocytes) | 59.85 Percentage of total white blood cells | Standard Deviation 8.07 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils/Leukocytes) | 1.70 Percentage of total white blood cells | Standard Deviation 5.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils/Leukocytes) | 1.35 Percentage of total white blood cells | Standard Deviation 4.76 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils/Leukocytes) | 0.40 Percentage of total white blood cells | Standard Deviation 5.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils/Leukocytes) | 1.17 Percentage of total white blood cells | Standard Deviation 5.31 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils/Leukocytes) | 1.14 Percentage of total white blood cells | Standard Deviation 8.14 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils/ Leukocytes) | -0.05 Percentage of total white blood cells | Standard Deviation 0.32 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes/Leukocytes) | -0.13 Percentage of total white blood cells | Standard Deviation 1.25 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils/Leukocytes) | 54.59 Percentage of total white blood cells | Standard Deviation 0.43 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils/ Leukocytes) | -0.53 Percentage of total white blood cells | Standard Deviation 2.58 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils/ Leukocytes) | -0.04 Percentage of total white blood cells | Standard Deviation 0.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils/ Leukocytes) | -0.07 Percentage of total white blood cells | Standard Deviation 0.31 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils/ Leukocytes) | 0.69 Percentage of total white blood cells | Standard Deviation 0.47 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils/Leukocytes) | 1.47 Percentage of total white blood cells | Standard Deviation 8.32 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils/ Leukocytes) | -0.24 Percentage of total white blood cells | Standard Deviation 1.78 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils/Leukocytes) | 1.01 Percentage of total white blood cells | Standard Deviation 7.54 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils/ Leukocytes) | -0.06 Percentage of total white blood cells | Standard Deviation 0.31 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes/Leukocytes) | -0.01 Percentage of total white blood cells | Standard Deviation 1.57 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils/Leukocytes) | 1.05 Percentage of total white blood cells | Standard Deviation 8.38 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes/Leukocytes) | -0.36 Percentage of total white blood cells | Standard Deviation 1.59 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes/ Leukocytes) | -0.43 Percentage of total white blood cells | Standard Deviation 7.03 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Eosinophils/ Leukocytes) | -0.42 Percentage of total white blood cells | Standard Deviation 2.33 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils/ Leukocytes) | 2.97 Percentage of total white blood cells | Standard Deviation 3.43 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes/ Leukocytes) | -0.41 Percentage of total white blood cells | Standard Deviation 6.56 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes/Leukocytes) | 7.55 Percentage of total white blood cells | Standard Deviation 1.67 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes/ Leukocytes) | -0.83 Percentage of total white blood cells | Standard Deviation 7.48 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes/Leukocytes) | 0.27 Percentage of total white blood cells | Standard Deviation 1.67 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils/ Leukocytes) | -0.43 Percentage of total white blood cells | Standard Deviation 2.43 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes/ Leukocytes) | -0.95 Percentage of total white blood cells | Standard Deviation 7.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes/ Leukocytes) | 34.20 Percentage of total white blood cells | Standard Deviation 9.42 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes/ Leukocytes) | -0.70 Percentage of total white blood cells | Standard Deviation 4.39 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Eosinophils/ Leukocytes) | -0.32 Percentage of total white blood cells | Standard Deviation 1.57 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes/Leukocytes) | 7.15 Percentage of total white blood cells | Standard Deviation 1.67 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils/ Leukocytes) | -0.27 Percentage of total white blood cells | Standard Deviation 1.43 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes/Leukocytes) | 0.08 Percentage of total white blood cells | Standard Deviation 1.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils/ Leukocytes) | -0.17 Percentage of total white blood cells | Standard Deviation 0.99 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes/Leukocytes) | 0.21 Percentage of total white blood cells | Standard Deviation 1.81 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils/ Leukocytes) | -0.13 Percentage of total white blood cells | Standard Deviation 1.17 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes/Leukocytes) | 0.24 Percentage of total white blood cells | Standard Deviation 1.52 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils/ Leukocytes) | 2.76 Percentage of total white blood cells | Standard Deviation 1.78 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils/Leukocytes) | 0.05 Percentage of total white blood cells | Standard Deviation 5.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes/Leukocytes) | 0.08 Percentage of total white blood cells | Standard Deviation 1.68 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils/ Leukocytes) | 0.01 Percentage of total white blood cells | Standard Deviation 0.19 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils/ Leukocytes) | 0.59 Percentage of total white blood cells | Standard Deviation 0.31 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils/Leukocytes) | 57.56 Percentage of total white blood cells | Standard Deviation 8.01 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils/ Leukocytes) | 0.05 Percentage of total white blood cells | Standard Deviation 0.21 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils/Leukocytes) | 1.36 Percentage of total white blood cells | Standard Deviation 6.75 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils/ Leukocytes) | 0.08 Percentage of total white blood cells | Standard Deviation 0.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils/Leukocytes) | 0.94 Percentage of total white blood cells | Standard Deviation 5.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes/ Leukocytes) | 0.68 Percentage of total white blood cells | Standard Deviation 4.85 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes/ Leukocytes) | -1.37 Percentage of total white blood cells | Standard Deviation 6.02 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils/Leukocytes) | -0.80 Percentage of total white blood cells | Standard Deviation 6.01 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes/ Leukocytes) | -0.07 Percentage of total white blood cells | Standard Deviation 4.94 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes/ Leukocytes) | 31.95 Percentage of total white blood cells | Standard Deviation 7.49 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils/ Leukocytes) | 0.07 Percentage of total white blood cells | Standard Deviation 0.2 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Platelets) | 9.5 10^9*cells/L | Standard Deviation 43.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Eosinophils) | 0.00 10^9*cells/L | Standard Deviation 0.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils) | -0.14 10^9*cells/L | Standard Deviation 0.79 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Leukocytes) | -0.20 10^9*cells/L | Standard Deviation 1.15 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes) | 0.02 10^9*cells/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Platelets) | 8.2 10^9*cells/L | Standard Deviation 54.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils) | 0.00 10^9*cells/L | Standard Deviation 0.06 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils) | -0.11 10^9*cells/L | Standard Deviation 1.16 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Leukocytes) | -0.19 10^9*cells/L | Standard Deviation 1.02 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes) | 0.00 10^9*cells/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Platelets) | 12.4 10^9*cells/L | Standard Deviation 28.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Leukocytes) | -0.12 10^9*cells/L | Standard Deviation 1.28 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Leukocytes) | 0.41 10^9*cells/L | Standard Deviation 2.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils) | 3.50 10^9*cells/L | Standard Deviation 1.34 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes) | 0.44 10^9*cells/L | Standard Deviation 0.13 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils) | 0.03 10^9*cells/L | Standard Deviation 0.04 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Platelets) | 273.6 10^9*cells/L | Standard Deviation 53.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils) | -0.08 10^9*cells/L | Standard Deviation 1.19 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes) | 1.98 10^9*cells/L | Standard Deviation 0.67 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes) | -0.14 10^9*cells/L | Standard Deviation 0.46 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.04 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils) | 0.02 10^9*cells/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes) | 0.01 10^9*cells/L | Standard Deviation 0.11 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Platelets) | 0.6 10^9*cells/L | Standard Deviation 36.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes) | -0.05 10^9*cells/L | Standard Deviation 0.36 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.05 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.04 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils) | -0.01 10^9*cells/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils) | 0.14 10^9*cells/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes) | -0.08 10^9*cells/L | Standard Deviation 0.38 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.04 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Leukocytes) | 6.09 10^9*cells/L | Standard Deviation 1.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils) | 0.11 10^9*cells/L | Standard Deviation 1.04 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes) | 0.01 10^9*cells/L | Standard Deviation 0.11 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes) | -0.06 10^9*cells/L | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils) | -0.01 10^9*cells/L | Standard Deviation 0.03 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes) | 1.90 10^9*cells/L | Standard Deviation 0.63 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils) | 0.19 10^9*cells/L | Standard Deviation 0.12 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Leukocytes) | -0.11 10^9*cells/L | Standard Deviation 1.07 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Eosinophils) | -0.02 10^9*cells/L | Standard Deviation 0.08 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils) | 0.00 10^9*cells/L | Standard Deviation 0.09 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils) | 0.02 10^9*cells/L | Standard Deviation 0.09 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils) | -0.01 10^9*cells/L | Standard Deviation 0.08 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils) | -0.15 10^9*cells/L | Standard Deviation 0.84 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Leukocytes) | 0.19 10^9*cells/L | Standard Deviation 1.84 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils) | 3.59 10^9*cells/L | Standard Deviation 1.33 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Platelets) | 270.8 10^9*cells/L | Standard Deviation 66.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Leukocytes) | -0.24 10^9*cells/L | Standard Deviation 0.99 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes) | -0.02 10^9*cells/L | Standard Deviation 0.14 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Platelets) | -3.9 10^9*cells/L | Standard Deviation 31.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Leukocytes) | 6.17 10^9*cells/L | Standard Deviation 1.89 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes) | -0.03 10^9*cells/L | Standard Deviation 0.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Platelets) | -2.1 10^9*cells/L | Standard Deviation 27.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils) | -0.02 10^9*cells/L | Standard Deviation 0.97 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes) | -0.03 10^9*cells/L | Standard Deviation 0.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Platelets) | -0.5 10^9*cells/L | Standard Deviation 33.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes) | -0.02 10^9*cells/L | Standard Deviation 0.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Platelets) | 5.7 10^9*cells/L | Standard Deviation 37.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes) | 0.47 10^9*cells/L | Standard Deviation 0.14 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils) | 0.05 10^9*cells/L | Standard Deviation 0.05 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Leukocytes) | -0.09 10^9*cells/L | Standard Deviation 0.96 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes) | -0.11 10^9*cells/L | Standard Deviation 0.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.02 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils) | 0.33 10^9*cells/L | Standard Deviation 1.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes) | -0.08 10^9*cells/L | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils) | 0.09 10^9*cells/L | Standard Deviation 0.86 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes) | -0.13 10^9*cells/L | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils) | -0.01 10^9*cells/L | Standard Deviation 0.04 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes) | -0.11 10^9*cells/L | Standard Deviation 0.33 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils) | -0.01 10^9*cells/L | Standard Deviation 0.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Leukocytes) | 6.32 10^9*cells/L | Standard Deviation 1.35 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Leukocytes) | -0.13 10^9*cells/L | Standard Deviation 0.97 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Leukocytes) | 0.16 10^9*cells/L | Standard Deviation 1.02 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Leukocytes) | 0.08 10^9*cells/L | Standard Deviation 1.98 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Leukocytes) | -0.05 10^9*cells/L | Standard Deviation 1.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Platelets) | 254.9 10^9*cells/L | Standard Deviation 37.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Platelets) | -6.0 10^9*cells/L | Standard Deviation 22.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Platelets) | 7.6 10^9*cells/L | Standard Deviation 35.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Platelets) | 14.7 10^9*cells/L | Standard Deviation 23.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Platelets) | 3.9 10^9*cells/L | Standard Deviation 28.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils) | 0.04 10^9*cells/L | Standard Deviation 0.05 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils) | -0.02 10^9*cells/L | Standard Deviation 0.04 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils) | -0.02 10^9*cells/L | Standard Deviation 0.04 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils) | -0.02 10^9*cells/L | Standard Deviation 0.06 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.05 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils) | 0.18 10^9*cells/L | Standard Deviation 0.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils) | -0.01 10^9*cells/L | Standard Deviation 0.07 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils) | 0.00 10^9*cells/L | Standard Deviation 0.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Eosinophils) | -0.01 10^9*cells/L | Standard Deviation 0.13 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes) | 1.78 10^9*cells/L | Standard Deviation 0.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes) | -0.10 10^9*cells/L | Standard Deviation 0.31 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes) | 0.04 10^9*cells/L | Standard Deviation 0.45 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes) | -0.07 10^9*cells/L | Standard Deviation 0.24 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes) | -0.07 10^9*cells/L | Standard Deviation 0.32 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes) | 0.51 10^9*cells/L | Standard Deviation 0.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes) | -0.02 10^9*cells/L | Standard Deviation 0.13 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes) | 0.01 10^9*cells/L | Standard Deviation 0.12 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes) | -0.06 10^9*cells/L | Standard Deviation 0.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes) | -0.03 10^9*cells/L | Standard Deviation 0.13 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils) | 3.81 10^9*cells/L | Standard Deviation 1.13 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils) | 0.03 10^9*cells/L | Standard Deviation 0.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils) | 0.14 10^9*cells/L | Standard Deviation 0.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils) | 0.22 10^9*cells/L | Standard Deviation 1.79 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils) | 0.05 10^9*cells/L | Standard Deviation 0.96 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils) | -0.03 10^9*cells/L | Standard Deviation 0.16 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.05 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Leukocytes) | -0.27 10^9*cells/L | Standard Deviation 1.44 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes) | -0.11 10^9*cells/L | Standard Deviation 0.41 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils) | -0.01 10^9*cells/L | Standard Deviation 0.04 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes) | -0.08 10^9*cells/L | Standard Deviation 0.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.04 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils) | -0.13 10^9*cells/L | Standard Deviation 1.24 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes) | -0.09 10^9*cells/L | Standard Deviation 0.47 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils) | 0.03 10^9*cells/L | Standard Deviation 0.05 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes) | -0.13 10^9*cells/L | Standard Deviation 0.39 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Platelets) | 1.2 10^9*cells/L | Standard Deviation 32.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes) | 0.47 10^9*cells/L | Standard Deviation 0.14 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Platelets) | 0.0 10^9*cells/L | Standard Deviation 30.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Leukocytes) | -0.25 10^9*cells/L | Standard Deviation 1.33 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes) | -0.05 10^9*cells/L | Standard Deviation 0.14 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Platelets) | -5.7 10^9*cells/L | Standard Deviation 29.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils) | 0.04 10^9*cells/L | Standard Deviation 1.73 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes) | -0.03 10^9*cells/L | Standard Deviation 0.11 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Platelets) | -5.5 10^9*cells/L | Standard Deviation 32.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils) | -0.13 10^9*cells/L | Standard Deviation 1.26 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes) | -0.03 10^9*cells/L | Standard Deviation 0.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Platelets) | 280.6 10^9*cells/L | Standard Deviation 62.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes) | 0.00 10^9*cells/L | Standard Deviation 0.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Leukocytes) | -0.12 10^9*cells/L | Standard Deviation 1.88 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils) | 3.51 10^9*cells/L | Standard Deviation 1.41 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Leukocytes) | -0.29 10^9*cells/L | Standard Deviation 1.55 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Leukocytes) | 6.31 10^9*cells/L | Standard Deviation 1.74 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils) | -0.03 10^9*cells/L | Standard Deviation 0.12 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils) | -0.08 10^9*cells/L | Standard Deviation 1.24 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils) | -0.05 10^9*cells/L | Standard Deviation 0.19 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils) | 0.20 10^9*cells/L | Standard Deviation 0.24 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Eosinophils) | -0.05 10^9*cells/L | Standard Deviation 0.17 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils) | -0.01 10^9*cells/L | Standard Deviation 0.04 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes) | 2.11 10^9*cells/L | Standard Deviation 0.66 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Platelets) | -3.0 10^9*cells/L | Standard Deviation 30.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Eosinophils) | -0.02 10^9*cells/L | Standard Deviation 0.07 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Eosinophils) | -0.02 10^9*cells/L | Standard Deviation 0.09 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Leukocytes) | -0.20 10^9*cells/L | Standard Deviation 1.04 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Lymphocytes) | -0.14 10^9*cells/L | Standard Deviation 0.39 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Basophils) | 0.01 10^9*cells/L | Standard Deviation 0.05 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Monocytes) | 0.00 10^9*cells/L | Standard Deviation 0.15 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Neutrophils) | 0.10 10^9*cells/L | Standard Deviation 0.95 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Platelets) | 277.0 10^9*cells/L | Standard Deviation 59.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Lymphocytes) | -0.02 10^9*cells/L | Standard Deviation 0.38 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Basophils) | 0.01 10^9*cells/L | Standard Deviation 0.04 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Eosinophils) | -0.02 10^9*cells/L | Standard Deviation 0.11 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Neutrophils) | -0.01 10^9*cells/L | Standard Deviation 1.39 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Basophils) | 0.01 10^9*cells/L | Standard Deviation 0.05 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Lymphocytes) | -0.05 10^9*cells/L | Standard Deviation 0.29 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Basophils) | 0.03 10^9*cells/L | Standard Deviation 0.04 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Monocytes) | 0.00 10^9*cells/L | Standard Deviation 0.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Neutrophils) | -0.16 10^9*cells/L | Standard Deviation 0.91 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Leukocytes) | 0.09 10^9*cells/L | Standard Deviation 1.18 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 16: Change from baseline (Lymphocytes) | 0.01 10^9*cells/L | Standard Deviation 0.36 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week16: Change from baseline (Platelets) | 9.5 10^9*cells/L | Standard Deviation 38 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Eosinophils) | -0.03 10^9*cells/L | Standard Deviation 0.09 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Leukocytes) | -0.12 10^9*cells/L | Standard Deviation 1.44 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Leukocytes) | 6.40 10^9*cells/L | Standard Deviation 1.76 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Monocytes) | 0.46 10^9*cells/L | Standard Deviation 0.17 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Platelets) | 1.3 10^9*cells/L | Standard Deviation 45.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Eosinophils) | 0.18 10^9*cells/L | Standard Deviation 0.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Neutrophils) | 3.73 10^9*cells/L | Standard Deviation 1.28 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Leukocytes) | -0.08 10^9*cells/L | Standard Deviation 1.59 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Monocytes) | -0.01 10^9*cells/L | Standard Deviation 0.11 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Platelets) | -1.4 10^9*cells/L | Standard Deviation 34.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Lymphocytes) | 2.00 10^9*cells/L | Standard Deviation 0.62 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 2: Change from baseline (Neutrophils) | 0.01 10^9*cells/L | Standard Deviation 1.32 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 12: Change from baseline (Basophils) | 0.00 10^9*cells/L | Standard Deviation 0.03 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Week 4: Change from baseline (Monocytes) | -0.02 10^9*cells/L | Standard Deviation 0.12 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals
Urine for urinalysis was collected and sent to the central laboratory for analysis. The evaluation of components in the urine samples such as bacteria, yeast, red blood cells (RBC), white blood cells (WBC), casts and crystals was performed by microscopy. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF \[low-power field\]) and high magnification (/HPF \[high-power field\]). Range and direction of scores microscopic identification of urine components: * Bacteria: none seen, 1+, 2+, 3+,4+, TNTC (too numerous to count). * Other urine components: none seen=normal; few, moderate, many, TNTC = abnormal. The higher the value, the higher the concentration of the component evaluated.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 4+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 3+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 2+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Granular Casts(/LPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 4+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): TNTC | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): None seen | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): TNTC | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): None seen | 4 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 1+ | 5 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): TNTC | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 2+ | 4 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 2+ | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): None seen | 3 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): None seen | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 3+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 1+ | 4 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): TNTC | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 4+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Triple Phosphate Crystals(/HPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): None seen | 10 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Few | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Triple Phosphate Crystals(/HPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (WBC Casts(/LPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Triple Phosphate Crystals(/HPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): None seen | 7 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (WBC Casts(/LPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 1+ | 7 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (WBC Casts(/LPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (WBC Casts(/LPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): TNTC | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (WBC Casts(/LPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Waxy Casts(/LPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Triple Phosphate Crystals(/HPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Waxy Casts(/LPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Waxy Casts(/LPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Waxy Casts(/LPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Few | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Few | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 4+ | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Waxy Casts(/LPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 2+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (RBC Casts(/LPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (RBC Casts(/LPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (RBC Casts(/LPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (RBC Casts(/LPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Triple Phosphate Crystals(/HPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (RBC Casts(/LPF)): None seen | 9 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16: (Granular Casts(/LPF)): None seen | 13 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 4+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12: (Granular Casts(/LPF)): None seen | 12 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4: (Granular Casts(/LPF)): None seen | 11 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2: (Granular Casts(/LPF)): None seen | 8 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): None seen | 6 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 3+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Triple Phosphate Crystals(/HPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Triple Phosphate Crystals(/HPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): TNTC | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Triple Phosphate Crystals(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Triple Phosphate Crystals(/HPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Triple Phosphate Crystals(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): None seen | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 1+ | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 4+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 4+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): TNTC | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): None seen | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 2+ | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): TNTC | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 4+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): None seen | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 1+ | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 1+ | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Granular Casts(/LPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2: (Granular Casts(/LPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 2+ | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4: (Granular Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12: (Granular Casts(/LPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16: (Granular Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (RBC Casts(/LPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (RBC Casts(/LPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 3+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (RBC Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (RBC Casts(/LPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (RBC Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): None seen | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Waxy Casts(/LPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Waxy Casts(/LPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 4+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Waxy Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Waxy Casts(/LPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Waxy Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (WBC Casts(/LPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (WBC Casts(/LPF)): None seen | 9 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): TNTC | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (WBC Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 2+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (WBC Casts(/LPF)): None seen | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (WBC Casts(/LPF)): None seen | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): None seen | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): None seen | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): None seen | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): None seen | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): None seen | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Few | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 4+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4: (Granular Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Triple Phosphate Crystals(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12: (Granular Casts(/LPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 2+ | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16: (Granular Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (RBC Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (RBC Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): None seen | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): None seen | 4 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (RBC Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (RBC Casts(/LPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (RBC Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Waxy Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Triple Phosphate Crystals(/HPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Waxy Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Waxy Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 4+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Waxy Casts(/LPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Waxy Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (WBC Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 1+ | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (WBC Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Few | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (WBC Casts(/LPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (WBC Casts(/LPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (WBC Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Triple Phosphate Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): None seen | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 4+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Triple Phosphate Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 1+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 4+ | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): None seen | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): None seen | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): None seen | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Triple Phosphate Crystals(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): TNTC | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): None seen | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 4+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 1+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 4+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 1+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Granular Casts(/LPF)): None seen | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2: (Granular Casts(/LPF)): None seen | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 2+ | 4 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4: (Granular Casts(/LPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): None seen | 16 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 4+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Few | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): None seen | 9 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12: (Granular Casts(/LPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16: (Granular Casts(/LPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 1+ | 6 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Many | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 1+ | 4 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (RBC Casts(/LPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (RBC Casts(/LPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Triple Phosphate Crystals(/HPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): None seen | 9 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): TNTC | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2: (Granular Casts(/LPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (RBC Casts(/LPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Triple Phosphate Crystals(/HPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (RBC Casts(/LPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Triple Phosphate Crystals(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (RBC Casts(/LPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): None seen | 16 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Triple Phosphate Crystals(/HPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): None seen | 6 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Waxy Casts(/LPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): None seen | 9 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 2+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Waxy Casts(/LPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Waxy Casts(/LPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): None seen | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Waxy Casts(/LPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 4+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 1+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Waxy Casts(/LPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Moderate | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Few | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (WBC Casts(/LPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 2+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 4+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 4+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Few | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 4+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): None seen | 14 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (WBC Casts(/LPF)): None seen | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): TNTC | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Granular Casts(/LPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Triple Phosphate Crystals(/HPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (WBC Casts(/LPF)): None seen | 15 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): TNTC | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (WBC Casts(/LPF)): None seen | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 2+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (WBC Casts(/LPF)): None seen | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): TNTC | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): None seen | 17 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): None seen | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 1+ | 5 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 2+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 3+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): 4+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Bacteria(/HPF)): TNTC | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): None seen | 6 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 1+ | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 2+ | 6 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 3+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): 4+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Bacteria(/HPF)): TNTC | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): None seen | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 1+ | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 2+ | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 3+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): 4+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Bacteria(/HPF)): TNTC | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): None seen | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 1+ | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 2+ | 5 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): 4+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Bacteria(/HPF)): TNTC | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): None seen | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 1+ | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 2+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 3+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): 4+ | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Bacteria(/HPF)): TNTC | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Yeast Cells(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): None seen | 17 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Yeast Cells(/HPF)): Few | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Yeast Cells(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Yeast Cells(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Yeast Cells(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Granular Casts(/LPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2: (Granular Casts(/LPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4: (Granular Casts(/LPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12: (Granular Casts(/LPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16: (Granular Casts(/LPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (RBC Casts(/LPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (RBC Casts(/LPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (RBC Casts(/LPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (RBC Casts(/LPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (RBC Casts(/LPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Waxy Casts(/LPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Waxy Casts(/LPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Waxy Casts(/LPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Waxy Casts(/LPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Waxy Casts(/LPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (WBC Casts(/LPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (WBC Casts(/LPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (WBC Casts(/LPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (WBC Casts(/LPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (WBC Casts(/LPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): None seen | 16 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Few | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): None seen | 17 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): None seen | 10 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): Many | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): None seen | 11 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Few | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Triple Phosphate Crystals(/HPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Triple Phosphate Crystals(/HPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Triple Phosphate Crystals(/HPF)): None seen | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Triple Phosphate Crystals(/HPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 16 (Triple Phosphate Crystals(/HPF)): None seen | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): None seen | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): None seen | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 2 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Few | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 4 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): None seen | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Few | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Week 12 (Uric Acid Crystals(/HPF)): Moderate | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): Many | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals | Baseline (Calcium Oxalate Crystals(/HPF)): TNTC | 0 Participants |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes
Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at high magnification (/HPF \[high-power field\]).
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Erythrocytes (/HPF)) | -0.1 cells/HPF | Standard Deviation 1.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Leukocytes (/HPF)) | -7.6 cells/HPF | Standard Deviation 21.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Erythrocytes (/HPF)) | -0.4 cells/HPF | Standard Deviation 2.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Leukocytes (/HPF)) | 6.4 cells/HPF | Standard Deviation 47.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Leukocytes (/HPF)) | -6.0 cells/HPF | Standard Deviation 20.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Erythrocytes (/HPF)) | -0.6 cells/HPF | Standard Deviation 2.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Erythrocytes (/HPF)) | 1.3 cells/HPF | Standard Deviation 1.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Leukocytes (/HPF)) | -6.7 cells/HPF | Standard Deviation 15.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Leukocytes (/HPF)) | 9.5 cells/HPF | Standard Deviation 16.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Erythrocytes (/HPF)) | -0.3 cells/HPF | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Erythrocytes (/HPF)) | -0.6 cells/HPF | Standard Deviation 0.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Erythrocytes (/HPF)) | 0.8 cells/HPF | Standard Deviation 1.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Erythrocytes (/HPF)) | 0.5 cells/HPF | Standard Deviation 1.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Erythrocytes (/HPF)) | -0.4 cells/HPF | Standard Deviation 0.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Erythrocytes (/HPF)) | -0.7 cells/HPF | Standard Deviation 1.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Leukocytes (/HPF)) | 2.6 cells/HPF | Standard Deviation 4.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Leukocytes (/HPF)) | 0.0 cells/HPF | Standard Deviation 3.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Leukocytes (/HPF)) | 1.0 cells/HPF | Standard Deviation 1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Leukocytes (/HPF)) | 3.5 cells/HPF | Standard Deviation 6.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Leukocytes (/HPF)) | 3.0 cells/HPF | Standard Deviation 4.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Leukocytes (/HPF)) | 1.6 cells/HPF | Standard Deviation 1.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Leukocytes (/HPF)) | 0.6 cells/HPF | Standard Deviation 3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Erythrocytes (/HPF)) | -2.7 cells/HPF | Standard Deviation 3.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Erythrocytes (/HPF)) | 0.4 cells/HPF | Standard Deviation 0.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Erythrocytes (/HPF)) | -1.0 cells/HPF | Standard Deviation 1.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Erythrocytes (/HPF)) | -1.5 cells/HPF | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Leukocytes (/HPF)) | 0.5 cells/HPF | Standard Deviation 2.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Erythrocytes (/HPF)) | 2.0 cells/HPF | Standard Deviation 2.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Leukocytes (/HPF)) | 3.0 cells/HPF | Standard Deviation 4.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Leukocytes (/HPF)) | 6.3 cells/HPF | Standard Deviation 11.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Erythrocytes (/HPF)) | -0.8 cells/HPF | Standard Deviation 4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Leukocytes (/HPF)) | 0.6 cells/HPF | Standard Deviation 1.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Erythrocytes (/HPF)) | 1.5 cells/HPF | Standard Deviation 2.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Erythrocytes (/HPF)) | -0.5 cells/HPF | Standard Deviation 3.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Leukocytes (/HPF)) | 5.3 cells/HPF | Standard Deviation 11.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Leukocytes (/HPF)) | 0.3 cells/HPF | Standard Deviation 4.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Leukocytes (/HPF)) | 0.6 cells/HPF | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Leukocytes (/HPF)) | -1.0 cells/HPF | Standard Deviation 2.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Erythrocytes (/HPF)) | 1.4 cells/HPF | Standard Deviation 3.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Erythrocytes (/HPF)) | 0.3 cells/HPF | Standard Deviation 2.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Erythrocytes (/HPF)) | 0.2 cells/HPF | Standard Deviation 1.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 12: Change from baseline (Leukocytes (/HPF)) | -1.5 cells/HPF | Standard Deviation 5.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Erythrocytes (/HPF)) | 0.1 cells/HPF | Standard Deviation 0.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Leukocytes (/HPF)) | 3.0 cells/HPF | Standard Deviation 5.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 16: Change from baseline (Leukocytes (/HPF)) | 13.3 cells/HPF | Standard Deviation 33.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Leukocytes (/HPF)) | -0.4 cells/HPF | Standard Deviation 6.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Baseline (Erythrocytes (/HPF)) | 0.6 cells/HPF | Standard Deviation 0.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Leukocytes (/HPF)) | 0.8 cells/HPF | Standard Deviation 5.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 4: Change from baseline (Erythrocytes (/HPF)) | 0.3 cells/HPF | Standard Deviation 1.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes | Week 2: Change from baseline (Erythrocytes (/HPF)) | 0.9 cells/HPF | Standard Deviation 3 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite
Urine for urinalysis was collected and sent to the central laboratory for analysis. Clinical relevance was judged by the investigator. Assessment was done using standard laboratory practice. For evaluation of the chemical properties of the urine sample test strips were used which have test pads of chemicals that change color when they come in contact with reagents. The degree of color change correlates with the amount of reagent present. Each color block represents a range of values. Range and direction of scores for reagents nitrite and urobilinogen: negative = normal; positive = abnormal. Range and direction of scores for all other reagents tested: negative = normal; trace, 1+, 2+, 3+ = abnormal, the higher the value, the higher the concentration of the reagent tested.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Negative | 43 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Positive | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Negative | 38 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Negative | 46 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 1+ | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Negative | 47 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Negative | 40 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Negative | 42 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Trace | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Urobilinogen): Negative | 41 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Urobilinogen): Negative | 43 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Urobilinogen): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Positive | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Urobilinogen): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Urobilinogen): Negative | 47 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Negative | 43 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 3+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Positive | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Negative | 42 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Negative | 39 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Negative | 40 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Positive | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Negative | 41 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): Negative | 47 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 1+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): Negative | 43 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): Negative | 41 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Positive | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Negative | 46 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Negative | 44 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Trace | 2 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 2+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Negative | 45 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Trace | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 3+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Negative | 42 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Negative | 46 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 2+ | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Trace | 1 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Negative | 41 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 1+ | 0 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Negative | 41 Participants |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Trace | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Negative | 27 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Positive | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Negative | 28 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Trace | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): 1+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Trace | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 1+ | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 1+ | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Urobilinogen): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Trace | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Negative | 28 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Trace | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Positive | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Urobilinogen): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Positive | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Trace | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Positive | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Urobilinogen): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Urobilinogen): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Urobilinogen): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Negative | 31 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Negative | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Negative | 29 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 3+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Positive | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 1+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Trace | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Trace | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 2+ | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Negative | 30 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Negative | 15 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Trace | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 3+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Negative | 13 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Trace | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 1+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Negative | 14 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Trace | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 3+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Trace | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Negative | 14 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 1+ | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 2+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Negative | 15 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Trace | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 1+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 2+ | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 3+ | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Urobilinogen): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Urobilinogen): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Urobilinogen): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Urobilinogen): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Urobilinogen): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Positive | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Positive | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Negative | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Positive | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Positive | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Negative | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Positive | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Positive | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Trace | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Positive | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Negative | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Negative | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Positive | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Trace | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 1+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Negative | 47 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Positive | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Urobilinogen): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Urobilinogen): Negative | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Negative | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Urobilinogen): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Trace | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Trace | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Positive | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Urobilinogen): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): Negative | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Trace | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Negative | 42 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 2+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Trace | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Negative | 48 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 1+ | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Negative | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Urobilinogen): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): Negative | 49 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Negative | 45 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Trace | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Negative | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Negative | 40 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 3+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Negative | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 2+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Trace | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Negative | 47 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Negative | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Negative | 48 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 1+ | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 2+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Trace | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Negative | 48 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 2+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Negative | 48 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Negative | 42 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): Negative | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 3+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 1+ | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Trace | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Trace | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 1+ | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Negative | 45 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Negative | 39 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): Trace | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 1+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Ketones): Negative | 43 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Positive | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Occult Blood): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Ketones): Negative | 48 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 1+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Negative | 49 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Ketones): Negative | 50 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 1+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Ketones): Negative | 50 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Negative | 47 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Protein): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Negative | 49 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Bilirubin): Negative | 44 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Bilirubin): Negative | 44 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 2+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Nitrite): Positive | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Protein): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Bilirubin): Negative | 48 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): Negative | 49 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Negative | 45 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): Trace | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Bilirubin): Negative | 51 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Negative | 42 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Bilirubin): Negative | 51 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Negative | 47 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Protein): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 3+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 3+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Negative | 43 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Negative | 48 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Glucose): Negative | 43 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Nitrite): Positive | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Protein): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 3+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Negative | 43 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): 1+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Glucose): Negative | 40 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Negative | 42 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Protein): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 3+ | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Urobilinogen): Negative | 51 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Urobilinogen): Negative | 51 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Nitrite): Positive | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Urobilinogen): Negative | 48 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Urobilinogen): Negative | 44 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Glucose): Negative | 46 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Negative | 47 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): 1+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Nitrite): Positive | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Trace | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Occult Blood): Negative | 47 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Urobilinogen): Negative | 44 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 4 (Occult Blood): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 3+ | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Negative | 42 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): Trace | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Glucose): Trace | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 1+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Trace | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Occult Blood): Negative | 47 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Baseline (Nitrite): Negative | 48 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 12 (Occult Blood): 3+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Trace | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 2 (Glucose): 2+ | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite | Week 16 (Ketones): Negative | 44 Participants |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts
Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF \[low-power field\]).
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 12: Change from baseline (Hyaline Casts (/LPF)) | -0.3 cells/LPF | Standard Deviation 2.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Baseline (Hyaline Casts (/LPF) | 1.9 cells/LPF | Standard Deviation 2 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 16: Change from baseline (Hyaline Casts (/LPF)) | -1.2 cells/LPF | Standard Deviation 2.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 2: Change from baseline (Hyaline Casts (/LPF)) | -1.1 cells/LPF | Standard Deviation 2.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 4: Change from baseline (Hyaline Casts (/LPF)) | -0.2 cells/LPF | Standard Deviation 3.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 12: Change from baseline (Hyaline Casts (/LPF)) | -0.1 cells/LPF | Standard Deviation 1.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 4: Change from baseline (Hyaline Casts (/LPF)) | -0.5 cells/LPF | Standard Deviation 1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 2: Change from baseline (Hyaline Casts (/LPF)) | -0.6 cells/LPF | Standard Deviation 1.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 16: Change from baseline (Hyaline Casts (/LPF)) | 0.7 cells/LPF | Standard Deviation 1.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Baseline (Hyaline Casts (/LPF) | 0.8 cells/LPF | Standard Deviation 1.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 4: Change from baseline (Hyaline Casts (/LPF)) | 5.3 cells/LPF | Standard Deviation 6.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Baseline (Hyaline Casts (/LPF) | 0.1 cells/LPF | Standard Deviation 0.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 2: Change from baseline (Hyaline Casts (/LPF)) | 0.0 cells/LPF | Standard Deviation 0 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 12: Change from baseline (Hyaline Casts (/LPF)) | 2.2 cells/LPF | Standard Deviation 4.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 16: Change from baseline (Hyaline Casts (/LPF)) | 0.5 cells/LPF | Standard Deviation 1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 16: Change from baseline (Hyaline Casts (/LPF)) | 0.1 cells/LPF | Standard Deviation 0.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Baseline (Hyaline Casts (/LPF) | 0.8 cells/LPF | Standard Deviation 1.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 12: Change from baseline (Hyaline Casts (/LPF)) | -0.3 cells/LPF | Standard Deviation 0.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 4: Change from baseline (Hyaline Casts (/LPF)) | 0.3 cells/LPF | Standard Deviation 1.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 2: Change from baseline (Hyaline Casts (/LPF)) | -0.1 cells/LPF | Standard Deviation 0.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 4: Change from baseline (Hyaline Casts (/LPF)) | -0.4 cells/LPF | Standard Deviation 1.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 12: Change from baseline (Hyaline Casts (/LPF)) | -2.8 cells/LPF | Standard Deviation 9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Baseline (Hyaline Casts (/LPF) | 1.7 cells/LPF | Standard Deviation 6.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 16: Change from baseline (Hyaline Casts (/LPF)) | -0.2 cells/LPF | Standard Deviation 0.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts | Week 2: Change from baseline (Hyaline Casts (/LPF)) | 0.1 cells/LPF | Standard Deviation 1.5 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH
Urine for urinalysis was collected and sent to the central laboratory for analysis. Urine pH was measured on a pH scale.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 12: Change from baseline (pH) | -0.05 pH | Standard Deviation 0.89 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Baseline (pH) | 6.00 pH | Standard Deviation 0.83 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 16: Change from baseline (pH) | 0.05 pH | Standard Deviation 1.13 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 2: Change from baseline (pH) | 0.10 pH | Standard Deviation 0.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 4: Change from baseline (pH) | -0.11 pH | Standard Deviation 0.85 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 12: Change from baseline (pH) | 0.18 pH | Standard Deviation 1.06 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 4: Change from baseline (pH) | 0.18 pH | Standard Deviation 1.31 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 2: Change from baseline (pH) | 0.26 pH | Standard Deviation 0.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 16: Change from baseline (pH) | 0.00 pH | Standard Deviation 1.12 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Baseline (pH) | 6.10 pH | Standard Deviation 0.89 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 4: Change from baseline (pH) | -0.09 pH | Standard Deviation 0.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Baseline (pH) | 6.09 pH | Standard Deviation 0.92 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 2: Change from baseline (pH) | -0.15 pH | Standard Deviation 0.95 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 12: Change from baseline (pH) | -0.19 pH | Standard Deviation 0.83 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 16: Change from baseline (pH) | -0.03 pH | Standard Deviation 0.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 16: Change from baseline (pH) | -0.19 pH | Standard Deviation 0.84 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Baseline (pH) | 6.21 pH | Standard Deviation 0.75 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 12: Change from baseline (pH) | -0.21 pH | Standard Deviation 0.78 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 4: Change from baseline (pH) | -0.25 pH | Standard Deviation 0.83 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 2: Change from baseline (pH) | -0.30 pH | Standard Deviation 0.83 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 4: Change from baseline (pH) | -0.09 pH | Standard Deviation 0.89 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 12: Change from baseline (pH) | -0.06 pH | Standard Deviation 0.79 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Baseline (pH) | 6.08 pH | Standard Deviation 0.72 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 16: Change from baseline (pH) | 0.07 pH | Standard Deviation 1.04 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH | Week 2: Change from baseline (pH) | -0.20 pH | Standard Deviation 0.83 |
Secondary
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity
Urine for urinalysis was collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 16: Change from baseline (Specific Gravity) | 0.0009 Unitless | Standard Deviation 0.0088 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Baseline (Specific Gravity) | 1.0167 Unitless | Standard Deviation 0.0063 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 2: Change from baseline (Specific Gravity) | -0.0002 Unitless | Standard Deviation 0.0066 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 4: Change from baseline (Specific Gravity) | -0.0008 Unitless | Standard Deviation 0.0078 |
| Placebo | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 12: Change from baseline (Specific Gravity) | 0.0020 Unitless | Standard Deviation 0.0068 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 12: Change from baseline (Specific Gravity) | 0.0015 Unitless | Standard Deviation 0.0102 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Baseline (Specific Gravity) | 1.0167 Unitless | Standard Deviation 0.0083 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 16: Change from baseline (Specific Gravity) | 0.0002 Unitless | Standard Deviation 0.0093 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 4: Change from baseline (Specific Gravity) | 0.0012 Unitless | Standard Deviation 0.0086 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 2: Change from baseline (Specific Gravity) | -0.0011 Unitless | Standard Deviation 0.0085 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 4: Change from baseline (Specific Gravity) | -0.0026 Unitless | Standard Deviation 0.0063 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 12: Change from baseline (Specific Gravity) | -0.0012 Unitless | Standard Deviation 0.006 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 2: Change from baseline (Specific Gravity) | 0.0001 Unitless | Standard Deviation 0.006 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Baseline (Specific Gravity) | 1.0166 Unitless | Standard Deviation 0.0063 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 16: Change from baseline (Specific Gravity) | -0.0011 Unitless | Standard Deviation 0.0059 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 4: Change from baseline (Specific Gravity) | 0.0015 Unitless | Standard Deviation 0.0067 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 2: Change from baseline (Specific Gravity) | 0.0005 Unitless | Standard Deviation 0.0068 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 16: Change from baseline (Specific Gravity) | 0.0020 Unitless | Standard Deviation 0.0066 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Baseline (Specific Gravity) | 1.0154 Unitless | Standard Deviation 0.0064 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 12: Change from baseline (Specific Gravity) | 0.0002 Unitless | Standard Deviation 0.0068 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Baseline (Specific Gravity) | 1.0171 Unitless | Standard Deviation 0.0084 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 4: Change from baseline (Specific Gravity) | 0.0003 Unitless | Standard Deviation 0.0079 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 12: Change from baseline (Specific Gravity) | 0.0011 Unitless | Standard Deviation 0.0072 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 2: Change from baseline (Specific Gravity) | -0.0006 Unitless | Standard Deviation 0.006 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity | Week 16: Change from baseline (Specific Gravity) | -0.0006 Unitless | Standard Deviation 0.0066 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin
Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Bilirubin) | -0.5 umol/L | Standard Deviation 2.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Bilirubin) | -0.1 umol/L | Standard Deviation 2.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Creatinine) | 68.8 umol/L | Standard Deviation 11.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Creatinine) | 1.0 umol/L | Standard Deviation 6.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Creatinine) | 0.1 umol/L | Standard Deviation 7.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Bilirubin) | 0.2 umol/L | Standard Deviation 2.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Bilirubin) | -0.1 umol/L | Standard Deviation 2.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Creatinine) | -0.9 umol/L | Standard Deviation 6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Creatinine) | 0.7 umol/L | Standard Deviation 8.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Bilirubin) | 9.1 umol/L | Standard Deviation 4.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Creatinine) | 0.8 umol/L | Standard Deviation 7.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Bilirubin) | -0.2 umol/L | Standard Deviation 2.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Bilirubin) | -0.3 umol/L | Standard Deviation 3.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Creatinine) | 1.5 umol/L | Standard Deviation 6.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Creatinine) | -0.2 umol/L | Standard Deviation 8.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Bilirubin) | 8.4 umol/L | Standard Deviation 2.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Creatinine) | 68.5 umol/L | Standard Deviation 11.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Bilirubin) | 0.7 umol/L | Standard Deviation 2.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Creatinine) | 0.6 umol/L | Standard Deviation 8.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Bilirubin) | 0.1 umol/L | Standard Deviation 2.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Bilirubin) | 0.1 umol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Creatinine) | -1.0 umol/L | Standard Deviation 7.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Bilirubin) | 0.4 umol/L | Standard Deviation 2.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Creatinine) | 2.1 umol/L | Standard Deviation 7.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Bilirubin) | 0.8 umol/L | Standard Deviation 2.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Creatinine) | 68.1 umol/L | Standard Deviation 14.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Creatinine) | 2.9 umol/L | Standard Deviation 9.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Creatinine) | 2.7 umol/L | Standard Deviation 9.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Creatinine) | 4.8 umol/L | Standard Deviation 5.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Creatinine) | 4.2 umol/L | Standard Deviation 11.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Creatinine) | 6.5 umol/L | Standard Deviation 8.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Bilirubin) | 8.9 umol/L | Standard Deviation 3.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Bilirubin) | 1.4 umol/L | Standard Deviation 2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Bilirubin) | 2.3 umol/L | Standard Deviation 2.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Bilirubin) | 1.8 umol/L | Standard Deviation 2.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Bilirubin) | 0.8 umol/L | Standard Deviation 2.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Creatinine) | -0.9 umol/L | Standard Deviation 8.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Creatinine) | 71.4 umol/L | Standard Deviation 11.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Bilirubin) | 1.1 umol/L | Standard Deviation 3.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Creatinine) | -0.5 umol/L | Standard Deviation 7.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Bilirubin) | 1.0 umol/L | Standard Deviation 3.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Creatinine) | 0.6 umol/L | Standard Deviation 7.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Bilirubin) | -0.8 umol/L | Standard Deviation 3.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Bilirubin) | 0.3 umol/L | Standard Deviation 3.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Creatinine) | 1.9 umol/L | Standard Deviation 7.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Creatinine) | 0.7 umol/L | Standard Deviation 6.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Bilirubin) | -0.2 umol/L | Standard Deviation 3.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Bilirubin) | 9.6 umol/L | Standard Deviation 5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Creatinine) | -0.2 umol/L | Standard Deviation 12.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Bilirubin) | 0.9 umol/L | Standard Deviation 2.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Creatinine) | 70.1 umol/L | Standard Deviation 11.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Bilirubin) | 1.7 umol/L | Standard Deviation 2.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 2: Change from baseline (Creatinine) | 0.6 umol/L | Standard Deviation 7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 8: Change from baseline (Creatinine) | 0.5 umol/L | Standard Deviation 9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 16: Change from baseline (Bilirubin) | -0.4 umol/L | Standard Deviation 2.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Creatinine) | -2.8 umol/L | Standard Deviation 8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Bilirubin) | 1.3 umol/L | Standard Deviation 3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Baseline (Bilirubin) | 8.1 umol/L | Standard Deviation 2.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 4: Change from baseline (Creatinine) | 0.2 umol/L | Standard Deviation 7.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin | Week 12: Change from baseline (Bilirubin) | 1.0 umol/L | Standard Deviation 2.7 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase
Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Aspartate Aminotransferase) | 24.7 U/L | Standard Deviation 6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Aspartate Aminotransferase) | 0.7 U/L | Standard Deviation 5.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Aspartate Aminotransferase) | 0.9 U/L | Standard Deviation 7.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Aspartate Aminotransferase) | -1.1 U/L | Standard Deviation 4.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Aspartate Aminotransferase) | 1.5 U/L | Standard Deviation 6.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Gamma Glutamyl Transferase) | -1.5 U/L | Standard Deviation 6.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Aspartate Aminotransferase) | -1.3 U/L | Standard Deviation 5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Creatine Kinase) | 15.5 U/L | Standard Deviation 106.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Gamma Glutamyl Transferase) | -0.7 U/L | Standard Deviation 8.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Gamma Glutamyl Transferase) | 3.0 U/L | Standard Deviation 14.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Creatine Kinase) | 7.2 U/L | Standard Deviation 49.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Creatine Kinase) | 28.2 U/L | Standard Deviation 161.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Gamma Glutamyl Transferase) | -0.2 U/L | Standard Deviation 11.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Creatine Kinase) | 7.3 U/L | Standard Deviation 37.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Gamma Glutamyl Transferase ) | 24.6 U/L | Standard Deviation 17.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alkaline Phosphatase) | 79.8 U/L | Standard Deviation 24.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alanine Aminotransferase) | 2.5 U/L | Standard Deviation 13.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alkaline Phosphatase) | -1.5 U/L | Standard Deviation 8.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alanine Aminotransferase) | -0.5 U/L | Standard Deviation 7.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alkaline Phosphatase) | -1.1 U/L | Standard Deviation 6.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Gamma Glutamyl Transferase) | -1.2 U/L | Standard Deviation 10.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alanine Aminotransferase) | -0.7 U/L | Standard Deviation 6.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alkaline Phosphatase) | -2.0 U/L | Standard Deviation 8.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Creatine Kinase) | -1.3 U/L | Standard Deviation 36.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alanine Aminotransferase) | 3.5 U/L | Standard Deviation 11.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alkaline Phosphatase) | -0.5 U/L | Standard Deviation 8.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alanine Aminotransferase) | 0.8 U/L | Standard Deviation 10.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alkaline Phosphatase) | -0.1 U/L | Standard Deviation 8.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Creatine Kinase) | 102.5 U/L | Standard Deviation 117.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alanine Aminotransferase) | 27.0 U/L | Standard Deviation 8.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Creatine Kinase) | 2.7 U/L | Standard Deviation 23.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Aspartate Aminotransferase) | 24.4 U/L | Standard Deviation 6.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Gamma Glutamyl Transferase) | 2.2 U/L | Standard Deviation 10.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Aspartate Aminotransferase) | 0.9 U/L | Standard Deviation 7.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alkaline Phosphatase) | 85.9 U/L | Standard Deviation 18.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Creatine Kinase) | 91.6 U/L | Standard Deviation 55.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Aspartate Aminotransferase) | 0.0 U/L | Standard Deviation 4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Gamma Glutamyl Transferase) | 0.1 U/L | Standard Deviation 9.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Aspartate Aminotransferase) | 0.3 U/L | Standard Deviation 3.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alanine Aminotransferase) | 2.0 U/L | Standard Deviation 9.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alkaline Phosphatase) | -5.0 U/L | Standard Deviation 10.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Aspartate Aminotransferase) | -0.2 U/L | Standard Deviation 3.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alanine Aminotransferase) | -0.1 U/L | Standard Deviation 5.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Aspartate Aminotransferase) | -0.5 U/L | Standard Deviation 4.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alkaline Phosphatase) | -1.9 U/L | Standard Deviation 14.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Gamma Glutamyl Transferase) | 1.5 U/L | Standard Deviation 9.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Creatine Kinase) | 30.6 U/L | Standard Deviation 127.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alanine Aminotransferase) | 0.7 U/L | Standard Deviation 6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Gamma Glutamyl Transferase) | -0.6 U/L | Standard Deviation 9.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alanine Aminotransferase) | -1.0 U/L | Standard Deviation 5.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alkaline Phosphatase) | -0.6 U/L | Standard Deviation 14.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Creatine Kinase) | 16.1 U/L | Standard Deviation 44.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alkaline Phosphatase) | -5.2 U/L | Standard Deviation 8.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Gamma Glutamyl Transferase) | 0.0 U/L | Standard Deviation 7.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alanine Aminotransferase) | 24.0 U/L | Standard Deviation 7.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alanine Aminotransferase) | -0.3 U/L | Standard Deviation 5.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Creatine Kinase) | 3.2 U/L | Standard Deviation 34.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Creatine Kinase) | 7.1 U/L | Standard Deviation 45.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Gamma Glutamyl Transferase ) | 25.1 U/L | Standard Deviation 15 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alkaline Phosphatase) | -3.2 U/L | Standard Deviation 8.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alkaline Phosphatase) | -4.9 U/L | Standard Deviation 10.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Creatine Kinase) | 104.2 U/L | Standard Deviation 62 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Creatine Kinase) | 8.7 U/L | Standard Deviation 59.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Creatine Kinase) | 4.3 U/L | Standard Deviation 44.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Creatine Kinase) | 158.1 U/L | Standard Deviation 580.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Creatine Kinase) | 11.7 U/L | Standard Deviation 116.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Creatine Kinase) | 5.6 U/L | Standard Deviation 54.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alkaline Phosphatase) | 80.6 U/L | Standard Deviation 19.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alkaline Phosphatase) | -2.2 U/L | Standard Deviation 6.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alkaline Phosphatase) | 3.2 U/L | Standard Deviation 13.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alkaline Phosphatase) | -1.0 U/L | Standard Deviation 6.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alkaline Phosphatase) | 0.2 U/L | Standard Deviation 11.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Aspartate Aminotransferase) | 24.4 U/L | Standard Deviation 5.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Aspartate Aminotransferase) | 0.1 U/L | Standard Deviation 4.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Aspartate Aminotransferase) | 4.6 U/L | Standard Deviation 17.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Aspartate Aminotransferase) | 3.4 U/L | Standard Deviation 24.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Aspartate Aminotransferase) | 0.9 U/L | Standard Deviation 8.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Aspartate Aminotransferase) | -2.4 U/L | Standard Deviation 3.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alanine Aminotransferase) | 23.9 U/L | Standard Deviation 10 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alanine Aminotransferase) | -0.7 U/L | Standard Deviation 5.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alanine Aminotransferase) | 16.4 U/L | Standard Deviation 70.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alanine Aminotransferase) | 0.6 U/L | Standard Deviation 12.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alanine Aminotransferase) | 4.3 U/L | Standard Deviation 21 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alanine Aminotransferase) | -3.5 U/L | Standard Deviation 6.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Gamma Glutamyl Transferase ) | 19.3 U/L | Standard Deviation 15.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Gamma Glutamyl Transferase) | -1.9 U/L | Standard Deviation 6.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Gamma Glutamyl Transferase) | 3.6 U/L | Standard Deviation 14.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Gamma Glutamyl Transferase) | 0.6 U/L | Standard Deviation 5.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Gamma Glutamyl Transferase) | 4.8 U/L | Standard Deviation 13.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Gamma Glutamyl Transferase) | 1.8 U/L | Standard Deviation 14.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alanine Aminotransferase) | 24.4 U/L | Standard Deviation 10 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Creatine Kinase) | -48.8 U/L | Standard Deviation 267 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alanine Aminotransferase) | -2.1 U/L | Standard Deviation 6.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Gamma Glutamyl Transferase ) | 25.5 U/L | Standard Deviation 23.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alkaline Phosphatase) | -3.8 U/L | Standard Deviation 8.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Creatine Kinase) | -39.2 U/L | Standard Deviation 280.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Creatine Kinase) | -13.3 U/L | Standard Deviation 77.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alanine Aminotransferase) | -0.4 U/L | Standard Deviation 9.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Gamma Glutamyl Transferase) | -2.7 U/L | Standard Deviation 8.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alkaline Phosphatase) | -0.1 U/L | Standard Deviation 9.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Gamma Glutamyl Transferase) | -2.8 U/L | Standard Deviation 13.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Creatine Kinase) | -36.9 U/L | Standard Deviation 275.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Creatine Kinase) | 161.8 U/L | Standard Deviation 291.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Gamma Glutamyl Transferase) | -3.5 U/L | Standard Deviation 10.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alkaline Phosphatase) | -2.5 U/L | Standard Deviation 6.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Gamma Glutamyl Transferase) | -0.7 U/L | Standard Deviation 10.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Aspartate Aminotransferase) | -1.8 U/L | Standard Deviation 6.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alanine Aminotransferase) | -0.6 U/L | Standard Deviation 6.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Aspartate Aminotransferase) | -1.8 U/L | Standard Deviation 6.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alkaline Phosphatase) | -5.1 U/L | Standard Deviation 10.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alkaline Phosphatase) | -4.4 U/L | Standard Deviation 11.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Aspartate Aminotransferase) | -2.0 U/L | Standard Deviation 7.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Creatine Kinase) | -30.2 U/L | Standard Deviation 293.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Aspartate Aminotransferase) | -1.8 U/L | Standard Deviation 4.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alkaline Phosphatase) | 91.3 U/L | Standard Deviation 43.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Gamma Glutamyl Transferase) | -3.0 U/L | Standard Deviation 14.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Aspartate Aminotransferase) | 24.8 U/L | Standard Deviation 8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alanine Aminotransferase) | 3.1 U/L | Standard Deviation 12 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Aspartate Aminotransferase) | -0.2 U/L | Standard Deviation 8.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alanine Aminotransferase) | -2.1 U/L | Standard Deviation 5.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Aspartate Aminotransferase) | -2.2 U/L | Standard Deviation 5.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alanine Aminotransferase) | 25.9 U/L | Standard Deviation 9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alkaline Phosphatase) | -4.5 U/L | Standard Deviation 8.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Gamma Glutamyl Transferase) | 3.3 U/L | Standard Deviation 22.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alanine Aminotransferase) | -3.0 U/L | Standard Deviation 7.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alkaline Phosphatase) | -4.5 U/L | Standard Deviation 12 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Creatine Kinase) | -44.3 U/L | Standard Deviation 154.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alanine Aminotransferase) | -1.1 U/L | Standard Deviation 9.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Alkaline Phosphatase) | -4.1 U/L | Standard Deviation 8.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Alanine Aminotransferase) | -0.7 U/L | Standard Deviation 10.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Alkaline Phosphatase) | -3.0 U/L | Standard Deviation 8.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Alanine Aminotransferase) | -1.2 U/L | Standard Deviation 9.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Alkaline Phosphatase) | 86.1 U/L | Standard Deviation 25.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alanine Aminotransferase) | -2.4 U/L | Standard Deviation 6.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Creatine Kinase) | -44.1 U/L | Standard Deviation 172.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Gamma Glutamyl Transferase) | 1.3 U/L | Standard Deviation 16.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Gamma Glutamyl Transferase ) | 25.9 U/L | Standard Deviation 28 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Creatine Kinase) | -40.3 U/L | Standard Deviation 174.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Creatine Kinase) | 139.8 U/L | Standard Deviation 159.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Gamma Glutamyl Transferase) | -1.0 U/L | Standard Deviation 7.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Creatine Kinase) | 4.0 U/L | Standard Deviation 76.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Gamma Glutamyl Transferase) | 1.4 U/L | Standard Deviation 14.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Aspartate Aminotransferase) | -0.3 U/L | Standard Deviation 6.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 4: Change from baseline (Creatine Kinase) | -40.1 U/L | Standard Deviation 163 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 8: Change from baseline (Aspartate Aminotransferase) | -1.2 U/L | Standard Deviation 5.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 2: Change from baseline (Aspartate Aminotransferase) | -2.3 U/L | Standard Deviation 6.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 12: Change from baseline (Aspartate Aminotransferase) | -2.0 U/L | Standard Deviation 7.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Baseline (Aspartate Aminotransferase) | 24.9 U/L | Standard Deviation 6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Gamma Glutamyl Transferase) | -0.2 U/L | Standard Deviation 16.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase | Week 16: Change from baseline (Alkaline Phosphatase) | -2.6 U/L | Standard Deviation 8 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C
Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Baseline | 39.22 mmol/mol | Standard Deviation 8.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 2: Change from baseline | -0.42 mmol/mol | Standard Deviation 1.46 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 4: Change from baseline | -0.29 mmol/mol | Standard Deviation 1.91 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 8: Change from baseline | -0.40 mmol/mol | Standard Deviation 2.38 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 12: Change from baseline | 0.07 mmol/mol | Standard Deviation 1.96 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 16: Change from baseline | -0.64 mmol/mol | Standard Deviation 2.41 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 12: Change from baseline | 0.84 mmol/mol | Standard Deviation 3.01 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 16: Change from baseline | 0.69 mmol/mol | Standard Deviation 2.64 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Baseline | 39.05 mmol/mol | Standard Deviation 5.82 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 4: Change from baseline | 0.00 mmol/mol | Standard Deviation 1.96 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 8: Change from baseline | 0.26 mmol/mol | Standard Deviation 2.16 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 2: Change from baseline | 0.04 mmol/mol | Standard Deviation 1.18 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 8: Change from baseline | 0.62 mmol/mol | Standard Deviation 2.13 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 12: Change from baseline | 1.57 mmol/mol | Standard Deviation 2.46 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Baseline | 35.84 mmol/mol | Standard Deviation 3.39 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 4: Change from baseline | 0.06 mmol/mol | Standard Deviation 1.47 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 2: Change from baseline | 0.19 mmol/mol | Standard Deviation 1.46 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 16: Change from baseline | 1.16 mmol/mol | Standard Deviation 2.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 8: Change from baseline | -0.13 mmol/mol | Standard Deviation 1.72 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 2: Change from baseline | -0.08 mmol/mol | Standard Deviation 1.35 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 4: Change from baseline | -0.02 mmol/mol | Standard Deviation 1.55 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 16: Change from baseline | -0.04 mmol/mol | Standard Deviation 2.22 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 12: Change from baseline | 0.55 mmol/mol | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Baseline | 38.78 mmol/mol | Standard Deviation 5.65 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 12: Change from baseline | -0.94 mmol/mol | Standard Deviation 5.33 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 4: Change from baseline | -0.43 mmol/mol | Standard Deviation 4.24 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 2: Change from baseline | -0.21 mmol/mol | Standard Deviation 2.32 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 16: Change from baseline | -1.07 mmol/mol | Standard Deviation 5.65 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Week 8: Change from baseline | -0.28 mmol/mol | Standard Deviation 5.11 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C | Baseline | 40.88 mmol/mol | Standard Deviation 10.97 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin
Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Protein) | -1.0 g/L | Standard Deviation 3.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Albumin) | 0.0 g/L | Standard Deviation 2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Albumin) | 44.7 g/L | Standard Deviation 2.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Albumin) | -0.9 g/L | Standard Deviation 2.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Protein) | -1.8 g/L | Standard Deviation 3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Protein) | 67.4 g/L | Standard Deviation 4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Albumin) | -0.8 g/L | Standard Deviation 2.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Albumin) | -1.3 g/L | Standard Deviation 1.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 3.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Protein) | -1.7 g/L | Standard Deviation 2.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Albumin) | -0.6 g/L | Standard Deviation 1.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Protein) | -2.1 g/L | Standard Deviation 4.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 3.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Protein) | -1.6 g/L | Standard Deviation 4.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Protein) | 67.5 g/L | Standard Deviation 4.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Albumin) | -0.4 g/L | Standard Deviation 2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Albumin) | -1.2 g/L | Standard Deviation 2.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Albumin) | 44.9 g/L | Standard Deviation 2.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Albumin) | -1.0 g/L | Standard Deviation 2.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 4.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Albumin) | -0.7 g/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Albumin) | -1.4 g/L | Standard Deviation 2.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Protein) | -2.3 g/L | Standard Deviation 4.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Albumin) | -0.9 g/L | Standard Deviation 2.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Albumin) | 0.1 g/L | Standard Deviation 3.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Protein) | 66.5 g/L | Standard Deviation 5.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Protein) | -0.4 g/L | Standard Deviation 3.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Protein) | 0.2 g/L | Standard Deviation 3.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Protein) | -1.7 g/L | Standard Deviation 4.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Protein) | -0.7 g/L | Standard Deviation 4.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Protein) | -1.9 g/L | Standard Deviation 5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Albumin) | 43.6 g/L | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Albumin) | -0.1 g/L | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Albumin) | 0.5 g/L | Standard Deviation 2.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Albumin) | 0.3 g/L | Standard Deviation 2.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Albumin) | -0.8 g/L | Standard Deviation 1.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Protein) | -1.6 g/L | Standard Deviation 2.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Albumin) | -0.6 g/L | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Protein) | 67.7 g/L | Standard Deviation 4.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Albumin) | -0.9 g/L | Standard Deviation 1.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Albumin) | -0.8 g/L | Standard Deviation 2.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Albumin) | 45.2 g/L | Standard Deviation 2.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Protein) | -2.0 g/L | Standard Deviation 3.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Protein) | -1.7 g/L | Standard Deviation 3.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 2.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Protein) | -1.8 g/L | Standard Deviation 3.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Albumin) | -0.6 g/L | Standard Deviation 2.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Protein) | -1.7 g/L | Standard Deviation 4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Protein) | -1.5 g/L | Standard Deviation 3.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Albumin) | -0.7 g/L | Standard Deviation 2.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Albumin) | -1.3 g/L | Standard Deviation 2.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 2: Change from baseline (Protein) | -2.1 g/L | Standard Deviation 3.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 4: Change from baseline (Albumin) | -0.7 g/L | Standard Deviation 2.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Protein) | 67.0 g/L | Standard Deviation 4.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Baseline (Albumin) | 44.2 g/L | Standard Deviation 3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Albumin) | -1.3 g/L | Standard Deviation 2.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 12: Change from baseline (Protein) | -1.8 g/L | Standard Deviation 3.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 16: Change from baseline (Albumin) | -0.4 g/L | Standard Deviation 2.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin | Week 8: Change from baseline (Protein) | -2.4 g/L | Standard Deviation 3.3 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride
Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Magnesium) | -0.011 mmol/L | Standard Deviation 0.066 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Potassium) | -0.13 mmol/L | Standard Deviation 0.39 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Chloride) | 0.2 mmol/L | Standard Deviation 2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Chloride) | 105.6 mmol/L | Standard Deviation 2.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Potassium) | 4.51 mmol/L | Standard Deviation 0.38 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Magnesium) | 0.809 mmol/L | Standard Deviation 0.075 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Glucose) | 5.06 mmol/L | Standard Deviation 0.83 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Urea Nitrogen) | -0.24 mmol/L | Standard Deviation 1.41 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16 Change from baseline (Calcium) | -0.005 mmol/L | Standard Deviation 0.09 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Calcium) | -0.046 mmol/L | Standard Deviation 0.081 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Bicarbonate) | 0.4 mmol/L | Standard Deviation 1.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Glucose) | 0.22 mmol/L | Standard Deviation 1.12 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Magnesium) | -0.024 mmol/L | Standard Deviation 0.052 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Chloride) | 0.2 mmol/L | Standard Deviation 1.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Potassium) | -0.02 mmol/L | Standard Deviation 0.35 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Bicarbonate) | 0.6 mmol/L | Standard Deviation 2.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Glucose) | 0.24 mmol/L | Standard Deviation 0.73 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Phosphate) | 0.00 mmol/L | Standard Deviation 0.14 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Sodium) | 0.0 mmol/L | Standard Deviation 1.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Sodium) | -0.2 mmol/L | Standard Deviation 1.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Bicarbonate) | 0.3 mmol/L | Standard Deviation 1.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Glucose) | 0.12 mmol/L | Standard Deviation 0.54 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Sodium) | -0.1 mmol/L | Standard Deviation 1.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Magnesium) | -0.033 mmol/L | Standard Deviation 0.059 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Potassium) | -0.04 mmol/L | Standard Deviation 0.39 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Bicarbonate) | 0.2 mmol/L | Standard Deviation 2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Glucose) | -0.06 mmol/L | Standard Deviation 0.94 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Calcium) | -0.006 mmol/L | Standard Deviation 0.088 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Chloride) | -0.5 mmol/L | Standard Deviation 1.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Chloride) | -0.5 mmol/L | Standard Deviation 2.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Bicarbonate) | 0.3 mmol/L | Standard Deviation 1.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Glucose) | 0.14 mmol/L | Standard Deviation 0.81 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Calcium) | -0.035 mmol/L | Standard Deviation 0.094 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Magnesium) | 0.005 mmol/L | Standard Deviation 0.056 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Potassium) | 0.06 mmol/L | Standard Deviation 0.39 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Bicarbonate) | 25.5 mmol/L | Standard Deviation 2.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Urea Nitrogen) | 5.74 mmol/L | Standard Deviation 1.49 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Urea Nitrogen) | -0.21 mmol/L | Standard Deviation 1.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Chloride) | -0.3 mmol/L | Standard Deviation 1.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Sodium) | -0.5 mmol/L | Standard Deviation 1.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.17 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Urea Nitrogen) | -0.43 mmol/L | Standard Deviation 1.05 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Phosphate) | 1.28 mmol/L | Standard Deviation 0.15 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Sodium) | -0.5 mmol/L | Standard Deviation 1.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Magnesium) | -0.008 mmol/L | Standard Deviation 0.054 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.16 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Urea Nitrogen) | -0.30 mmol/L | Standard Deviation 1.58 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Potassium) | -0.10 mmol/L | Standard Deviation 0.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Sodium) | 141.3 mmol/L | Standard Deviation 2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Calcium) | 2.348 mmol/L | Standard Deviation 0.082 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Phosphate) | -0.01 mmol/L | Standard Deviation 0.13 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Urea Nitrogen) | -0.23 mmol/L | Standard Deviation 1.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Calcium) | -0.008 mmol/L | Standard Deviation 0.109 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Sodium) | -0.6 mmol/L | Standard Deviation 2.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Urea Nitrogen) | -0.17 mmol/L | Standard Deviation 1.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Phosphate) | 0.00 mmol/L | Standard Deviation 0.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Urea Nitrogen) | -0.19 mmol/L | Standard Deviation 1.32 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Chloride) | 0.3 mmol/L | Standard Deviation 2.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Phosphate) | 1.28 mmol/L | Standard Deviation 0.15 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Calcium) | 2.354 mmol/L | Standard Deviation 0.093 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16 Change from baseline (Calcium) | -0.033 mmol/L | Standard Deviation 0.093 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Calcium) | -0.052 mmol/L | Standard Deviation 0.082 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Calcium) | -0.018 mmol/L | Standard Deviation 0.091 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Calcium) | -0.035 mmol/L | Standard Deviation 0.077 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Sodium) | -0.1 mmol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Calcium) | -0.034 mmol/L | Standard Deviation 0.085 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Sodium) | 0.1 mmol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Chloride) | 105.4 mmol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Potassium) | 4.43 mmol/L | Standard Deviation 0.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Sodium) | 141.6 mmol/L | Standard Deviation 2.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Magnesium) | -0.043 mmol/L | Standard Deviation 0.069 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Potassium) | -0.08 mmol/L | Standard Deviation 0.36 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Chloride) | -0.1 mmol/L | Standard Deviation 2.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Magnesium) | -0.025 mmol/L | Standard Deviation 0.06 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Potassium) | -0.09 mmol/L | Standard Deviation 0.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Magnesium) | -0.016 mmol/L | Standard Deviation 0.065 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Potassium) | -0.10 mmol/L | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Magnesium) | -0.035 mmol/L | Standard Deviation 0.057 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Potassium) | -0.07 mmol/L | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Sodium) | -0.2 mmol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Magnesium) | -0.027 mmol/L | Standard Deviation 0.07 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Potassium) | -0.10 mmol/L | Standard Deviation 0.33 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Chloride) | 0.2 mmol/L | Standard Deviation 2.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Magnesium) | 0.833 mmol/L | Standard Deviation 0.084 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Glucose) | 5.32 mmol/L | Standard Deviation 1.11 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Chloride) | -0.3 mmol/L | Standard Deviation 2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Bicarbonate) | -0.1 mmol/L | Standard Deviation 2.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Glucose) | -0.07 mmol/L | Standard Deviation 0.92 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Bicarbonate) | -0.4 mmol/L | Standard Deviation 2.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Glucose) | 0.02 mmol/L | Standard Deviation 0.87 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Bicarbonate) | 0.0 mmol/L | Standard Deviation 2.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Glucose) | -0.15 mmol/L | Standard Deviation 1.15 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Sodium) | -0.8 mmol/L | Standard Deviation 2.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Bicarbonate) | -0.1 mmol/L | Standard Deviation 2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Glucose) | -0.09 mmol/L | Standard Deviation 1.06 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Bicarbonate) | 0.0 mmol/L | Standard Deviation 2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Glucose) | 0.06 mmol/L | Standard Deviation 1.03 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Chloride) | -0.2 mmol/L | Standard Deviation 1.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Bicarbonate) | 26.6 mmol/L | Standard Deviation 3.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Urea Nitrogen) | 5.64 mmol/L | Standard Deviation 1.54 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Phosphate) | -0.01 mmol/L | Standard Deviation 0.16 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Urea Nitrogen) | 0.04 mmol/L | Standard Deviation 1.21 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.17 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Urea Nitrogen) | 0.12 mmol/L | Standard Deviation 0.95 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.15 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Urea Nitrogen) | -0.34 mmol/L | Standard Deviation 1.18 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Phosphate) | 0.00 mmol/L | Standard Deviation 0.16 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Urea Nitrogen) | 0.17 mmol/L | Standard Deviation 1.25 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Sodium) | 141.6 mmol/L | Standard Deviation 2.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Sodium) | -0.6 mmol/L | Standard Deviation 2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Sodium) | -0.9 mmol/L | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Sodium) | -0.6 mmol/L | Standard Deviation 1.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Sodium) | -0.9 mmol/L | Standard Deviation 1.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Sodium) | -0.1 mmol/L | Standard Deviation 2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Potassium) | 4.23 mmol/L | Standard Deviation 0.33 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Potassium) | 0.06 mmol/L | Standard Deviation 0.35 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Potassium) | 0.06 mmol/L | Standard Deviation 0.27 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Potassium) | -0.05 mmol/L | Standard Deviation 0.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Potassium) | 0.10 mmol/L | Standard Deviation 0.41 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Potassium) | -0.04 mmol/L | Standard Deviation 0.33 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Glucose) | 5.16 mmol/L | Standard Deviation 0.71 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Glucose) | 0.04 mmol/L | Standard Deviation 1.01 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Glucose) | -0.24 mmol/L | Standard Deviation 1.08 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Glucose) | -0.13 mmol/L | Standard Deviation 1.17 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Glucose) | 0.13 mmol/L | Standard Deviation 0.55 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Glucose) | 0.10 mmol/L | Standard Deviation 0.94 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Urea Nitrogen) | 5.70 mmol/L | Standard Deviation 1.45 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Urea Nitrogen) | 0.50 mmol/L | Standard Deviation 1.35 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Urea Nitrogen) | 0.13 mmol/L | Standard Deviation 1.71 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Urea Nitrogen) | 0.45 mmol/L | Standard Deviation 2.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Urea Nitrogen) | -0.03 mmol/L | Standard Deviation 1.57 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Calcium) | 2.325 mmol/L | Standard Deviation 0.091 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Calcium) | 0.011 mmol/L | Standard Deviation 0.102 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Calcium) | 0.028 mmol/L | Standard Deviation 0.068 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Calcium) | 0.002 mmol/L | Standard Deviation 0.091 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Calcium) | 0.014 mmol/L | Standard Deviation 0.108 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16 Change from baseline (Calcium) | 0.003 mmol/L | Standard Deviation 0.097 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Phosphate) | 1.17 mmol/L | Standard Deviation 0.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Phosphate) | 0.03 mmol/L | Standard Deviation 0.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Phosphate) | 0.05 mmol/L | Standard Deviation 0.09 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Phosphate) | 0.07 mmol/L | Standard Deviation 0.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Phosphate) | 0.06 mmol/L | Standard Deviation 0.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Phosphate) | 0.00 mmol/L | Standard Deviation 0.14 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Bicarbonate) | 26.2 mmol/L | Standard Deviation 3.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Bicarbonate) | -0.6 mmol/L | Standard Deviation 2.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Bicarbonate) | -0.1 mmol/L | Standard Deviation 2.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Bicarbonate) | -0.2 mmol/L | Standard Deviation 2.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Bicarbonate) | -0.5 mmol/L | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Bicarbonate) | -0.5 mmol/L | Standard Deviation 2.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Magnesium) | 0.826 mmol/L | Standard Deviation 0.075 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Magnesium) | -0.009 mmol/L | Standard Deviation 0.065 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Magnesium) | 0.002 mmol/L | Standard Deviation 0.052 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Magnesium) | 0.010 mmol/L | Standard Deviation 0.048 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Magnesium) | -0.035 mmol/L | Standard Deviation 0.058 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Magnesium) | -0.022 mmol/L | Standard Deviation 0.063 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Chloride) | 105.5 mmol/L | Standard Deviation 2.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Chloride) | 0.3 mmol/L | Standard Deviation 2.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Chloride) | -0.7 mmol/L | Standard Deviation 2.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Chloride) | -0.4 mmol/L | Standard Deviation 1.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Chloride) | -0.3 mmol/L | Standard Deviation 1.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Chloride) | 0.6 mmol/L | Standard Deviation 2.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Urea Nitrogen) | 0.53 mmol/L | Standard Deviation 1.58 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Phosphate) | -0.01 mmol/L | Standard Deviation 0.15 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Urea Nitrogen) | 0.36 mmol/L | Standard Deviation 1.42 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Phosphate) | 0.02 mmol/L | Standard Deviation 0.18 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Urea Nitrogen) | 0.50 mmol/L | Standard Deviation 1.25 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Phosphate) | 0.02 mmol/L | Standard Deviation 0.19 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Urea Nitrogen) | 5.34 mmol/L | Standard Deviation 1.51 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Sodium) | 0.1 mmol/L | Standard Deviation 2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Phosphate) | -0.01 mmol/L | Standard Deviation 0.17 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Glucose) | 0.09 mmol/L | Standard Deviation 1.02 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Sodium) | 141.2 mmol/L | Standard Deviation 1.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Bicarbonate) | 26.7 mmol/L | Standard Deviation 2.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Glucose) | 0.21 mmol/L | Standard Deviation 1.48 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Chloride) | 0.3 mmol/L | Standard Deviation 2.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Bicarbonate) | -0.5 mmol/L | Standard Deviation 2.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Glucose) | 0.01 mmol/L | Standard Deviation 1.09 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Bicarbonate) | -0.4 mmol/L | Standard Deviation 2.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Glucose) | 0.02 mmol/L | Standard Deviation 0.87 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Bicarbonate) | -0.6 mmol/L | Standard Deviation 1.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Glucose) | 0.28 mmol/L | Standard Deviation 0.97 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Sodium) | -0.3 mmol/L | Standard Deviation 1.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Bicarbonate) | -0.6 mmol/L | Standard Deviation 1.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Glucose) | 5.04 mmol/L | Standard Deviation 0.74 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Bicarbonate) | -0.3 mmol/L | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Potassium) | 0.04 mmol/L | Standard Deviation 0.45 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Chloride) | 0.5 mmol/L | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Magnesium) | 0.821 mmol/L | Standard Deviation 0.067 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Potassium) | 0.03 mmol/L | Standard Deviation 0.51 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Magnesium) | -0.013 mmol/L | Standard Deviation 0.066 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Potassium) | 0.02 mmol/L | Standard Deviation 0.51 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Magnesium) | -0.017 mmol/L | Standard Deviation 0.061 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Potassium) | -0.02 mmol/L | Standard Deviation 0.45 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Sodium) | -0.5 mmol/L | Standard Deviation 1.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Magnesium) | 0.005 mmol/L | Standard Deviation 0.077 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Potassium) | 0.01 mmol/L | Standard Deviation 0.44 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Chloride) | 0.1 mmol/L | Standard Deviation 1.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Magnesium) | -0.012 mmol/L | Standard Deviation 0.07 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Potassium) | 4.37 mmol/L | Standard Deviation 0.44 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Chloride) | 0.5 mmol/L | Standard Deviation 2.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Magnesium) | -0.025 mmol/L | Standard Deviation 0.057 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Sodium) | -0.2 mmol/L | Standard Deviation 2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Calcium) | -0.018 mmol/L | Standard Deviation 0.099 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Chloride) | 104.8 mmol/L | Standard Deviation 2.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Calcium) | -0.021 mmol/L | Standard Deviation 0.108 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Calcium) | -0.019 mmol/L | Standard Deviation 0.079 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Calcium) | -0.014 mmol/L | Standard Deviation 0.097 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Calcium) | 2.347 mmol/L | Standard Deviation 0.117 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16 Change from baseline (Calcium) | -0.009 mmol/L | Standard Deviation 0.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Urea Nitrogen) | 0.24 mmol/L | Standard Deviation 1.11 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Sodium) | 0.0 mmol/L | Standard Deviation 2.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Phosphate) | 1.26 mmol/L | Standard Deviation 0.16 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Urea Nitrogen) | 0.31 mmol/L | Standard Deviation 1.09 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Phosphate) | 0.00 mmol/L | Standard Deviation 0.15 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Chloride) | 0.5 mmol/L | Standard Deviation 2.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Calcium) | -0.036 mmol/L | Standard Deviation 0.094 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Chloride) | 0.3 mmol/L | Standard Deviation 1.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Phosphate) | -0.03 mmol/L | Standard Deviation 0.15 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Urea Nitrogen) | 0.12 mmol/L | Standard Deviation 1.22 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16 Change from baseline (Calcium) | -0.027 mmol/L | Standard Deviation 0.104 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Chloride) | -0.1 mmol/L | Standard Deviation 1.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Magnesium) | -0.037 mmol/L | Standard Deviation 0.057 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Urea Nitrogen) | 0.24 mmol/L | Standard Deviation 1.15 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Potassium) | -0.11 mmol/L | Standard Deviation 0.42 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Sodium) | 0.1 mmol/L | Standard Deviation 1.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Urea Nitrogen) | -0.01 mmol/L | Standard Deviation 1.25 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Phosphate) | -0.06 mmol/L | Standard Deviation 0.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Urea Nitrogen) | 5.31 mmol/L | Standard Deviation 1.26 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Sodium) | -0.5 mmol/L | Standard Deviation 1.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Phosphate) | -0.02 mmol/L | Standard Deviation 0.17 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Magnesium) | -0.017 mmol/L | Standard Deviation 0.06 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Phosphate) | -0.01 mmol/L | Standard Deviation 0.13 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Glucose) | -0.43 mmol/L | Standard Deviation 1.58 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Potassium) | -0.13 mmol/L | Standard Deviation 0.31 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Calcium) | -0.042 mmol/L | Standard Deviation 0.077 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Calcium) | -0.050 mmol/L | Standard Deviation 0.101 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Bicarbonate) | 26.0 mmol/L | Standard Deviation 2.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Glucose) | -0.34 mmol/L | Standard Deviation 1.82 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Sodium) | 141.3 mmol/L | Standard Deviation 2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Magnesium) | -0.008 mmol/L | Standard Deviation 0.063 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Potassium) | -0.07 mmol/L | Standard Deviation 0.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Bicarbonate) | -0.2 mmol/L | Standard Deviation 2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Glucose) | -0.12 mmol/L | Standard Deviation 1.35 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Chloride) | 105.3 mmol/L | Standard Deviation 2.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Chloride) | 0.2 mmol/L | Standard Deviation 2.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Urea Nitrogen) | -0.03 mmol/L | Standard Deviation 1.34 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Bicarbonate) | 0.0 mmol/L | Standard Deviation 1.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Glucose) | -0.29 mmol/L | Standard Deviation 2.39 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Calcium) | -0.042 mmol/L | Standard Deviation 0.084 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 4: Change from baseline (Sodium) | 0.0 mmol/L | Standard Deviation 1.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Magnesium) | -0.016 mmol/L | Standard Deviation 0.059 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 8: Change from baseline (Bicarbonate) | 0.3 mmol/L | Standard Deviation 1.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 2: Change from baseline (Glucose) | 0.21 mmol/L | Standard Deviation 1.89 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Potassium) | 4.36 mmol/L | Standard Deviation 0.45 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Calcium) | 2.342 mmol/L | Standard Deviation 0.091 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Phosphate) | 1.22 mmol/L | Standard Deviation 0.15 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Bicarbonate) | -0.2 mmol/L | Standard Deviation 1.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Glucose) | 5.81 mmol/L | Standard Deviation 2.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Sodium) | -0.1 mmol/L | Standard Deviation 1.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Chloride) | 0.1 mmol/L | Standard Deviation 2.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Magnesium) | -0.022 mmol/L | Standard Deviation 0.052 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Bicarbonate) | -0.1 mmol/L | Standard Deviation 2.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Potassium) | -0.16 mmol/L | Standard Deviation 0.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 16: Change from baseline (Sodium) | -0.3 mmol/L | Standard Deviation 1.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Urea Nitrogen) | -0.10 mmol/L | Standard Deviation 1.31 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Chloride) | 0.8 mmol/L | Standard Deviation 2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Baseline (Magnesium) | 0.817 mmol/L | Standard Deviation 0.076 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride | Week 12: Change from baseline (Potassium) | -0.16 mmol/L | Standard Deviation 0.4 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR)
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Baseline | 162.6 mSec | Standard Deviation 21.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 2: Change from baseline | 1.2 mSec | Standard Deviation 9.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 4: Change from baseline | 0.0 mSec | Standard Deviation 11.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 8: Change from baseline | 1.5 mSec | Standard Deviation 15.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 12: Change from baseline | 1.6 mSec | Standard Deviation 11.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 16: Change from baseline | 0.4 mSec | Standard Deviation 11.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 12: Change from baseline | 3.9 mSec | Standard Deviation 11.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 16: Change from baseline | 2.2 mSec | Standard Deviation 13.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Baseline | 167.8 mSec | Standard Deviation 16.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 4: Change from baseline | 5.9 mSec | Standard Deviation 12.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 8: Change from baseline | 3.6 mSec | Standard Deviation 10.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 2: Change from baseline | 4.6 mSec | Standard Deviation 11.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 8: Change from baseline | -0.1 mSec | Standard Deviation 12.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 12: Change from baseline | 0.7 mSec | Standard Deviation 16.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Baseline | 162.9 mSec | Standard Deviation 21.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 4: Change from baseline | 2.9 mSec | Standard Deviation 12.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 2: Change from baseline | 5.2 mSec | Standard Deviation 11.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 16: Change from baseline | 2.4 mSec | Standard Deviation 16 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 8: Change from baseline | 4.3 mSec | Standard Deviation 10.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 2: Change from baseline | 3.0 mSec | Standard Deviation 10.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 4: Change from baseline | 3.8 mSec | Standard Deviation 17.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 16: Change from baseline | 2.8 mSec | Standard Deviation 11.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 12: Change from baseline | 1.9 mSec | Standard Deviation 11.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Baseline | 157.2 mSec | Standard Deviation 21.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 12: Change from baseline | -1.5 mSec | Standard Deviation 16.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 4: Change from baseline | 1.8 mSec | Standard Deviation 13.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 2: Change from baseline | -2.2 mSec | Standard Deviation 16.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 16: Change from baseline | -0.4 mSec | Standard Deviation 13.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Week 8: Change from baseline | -1.1 mSec | Standard Deviation 14.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) | Baseline | 164.2 mSec | Standard Deviation 25.8 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT)
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 4: Change from baseline | 4.7 mSec | Standard Deviation 18.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Baseline | 394.5 mSec | Standard Deviation 31.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 8: Change from baseline | 2.0 mSec | Standard Deviation 19 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 16: Change from baseline | -1.7 mSec | Standard Deviation 23.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 2: Change from baseline | 3.6 mSec | Standard Deviation 18 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 12: Change from baseline | 1.4 mSec | Standard Deviation 25.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Baseline | 397.2 mSec | Standard Deviation 28.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 2: Change from baseline | 0.2 mSec | Standard Deviation 17.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 8: Change from baseline | 1.5 mSec | Standard Deviation 17.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 12: Change from baseline | 0.8 mSec | Standard Deviation 21.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 16: Change from baseline | -4.7 mSec | Standard Deviation 24.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 4: Change from baseline | -0.1 mSec | Standard Deviation 18.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 12: Change from baseline | -8.9 mSec | Standard Deviation 20.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 16: Change from baseline | -3.2 mSec | Standard Deviation 27.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 2: Change from baseline | 1.1 mSec | Standard Deviation 21.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 4: Change from baseline | 4.8 mSec | Standard Deviation 35.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Baseline | 403.5 mSec | Standard Deviation 26.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 8: Change from baseline | 6.5 mSec | Standard Deviation 28.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 12: Change from baseline | -1.1 mSec | Standard Deviation 32.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 8: Change from baseline | 0.5 mSec | Standard Deviation 34.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Baseline | 402.3 mSec | Standard Deviation 40.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 2: Change from baseline | -0.9 mSec | Standard Deviation 35.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 16: Change from baseline | -4.1 mSec | Standard Deviation 38.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 4: Change from baseline | 0.2 mSec | Standard Deviation 28.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 16: Change from baseline | -2.4 mSec | Standard Deviation 25.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Baseline | 401.2 mSec | Standard Deviation 28 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 2: Change from baseline | -3.2 mSec | Standard Deviation 25.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 4: Change from baseline | 0.8 mSec | Standard Deviation 21.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 8: Change from baseline | -4.0 mSec | Standard Deviation 20.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) | Week 12: Change from baseline | 1.0 mSec | Standard Deviation 19.5 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc)
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTc: QT corrected interval.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Baseline | 410.6 mSec | Standard Deviation 20.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 2: Change from baseline | 1.6 mSec | Standard Deviation 14.3 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 4: Change from baseline | 5.6 mSec | Standard Deviation 16.1 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 8: Change from baseline | -3.9 mSec | Standard Deviation 18.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 12: Change from baseline | -2.4 mSec | Standard Deviation 20.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 16: Change from baseline | 2.8 mSec | Standard Deviation 14.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 12: Change from baseline | -3.2 mSec | Standard Deviation 14.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 16: Change from baseline | -4.8 mSec | Standard Deviation 13.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Baseline | 417.9 mSec | Standard Deviation 21.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 4: Change from baseline | -5.4 mSec | Standard Deviation 11.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 8: Change from baseline | -3.8 mSec | Standard Deviation 12.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 2: Change from baseline | -2.4 mSec | Standard Deviation 11.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 8: Change from baseline | 2.3 mSec | Standard Deviation 10.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 12: Change from baseline | -3.1 mSec | Standard Deviation 14.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Baseline | 416.4 mSec | Standard Deviation 14.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 4: Change from baseline | 1.7 mSec | Standard Deviation 19.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 2: Change from baseline | 2.9 mSec | Standard Deviation 14.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 16: Change from baseline | 4.3 mSec | Standard Deviation 17.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 8: Change from baseline | -2.2 mSec | Standard Deviation 27.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 2: Change from baseline | -4.9 mSec | Standard Deviation 28.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 4: Change from baseline | -2.9 mSec | Standard Deviation 24.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 16: Change from baseline | -4.5 mSec | Standard Deviation 31.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 12: Change from baseline | -4.7 mSec | Standard Deviation 31.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Baseline | 415.9 mSec | Standard Deviation 29.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 12: Change from baseline | 0.5 mSec | Standard Deviation 14.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 4: Change from baseline | 0.2 mSec | Standard Deviation 16.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 2: Change from baseline | -2.1 mSec | Standard Deviation 15.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 16: Change from baseline | -1.6 mSec | Standard Deviation 13.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Week 8: Change from baseline | 1.2 mSec | Standard Deviation 14.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) | Baseline | 415.2 mSec | Standard Deviation 22.1 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF)
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTcF: QT interval with Fridericia's correction.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Baseline | 407.2 mSec | Standard Deviation 20.6 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 2: Change from baseline | 1.2 mSec | Standard Deviation 13.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 4: Change from baseline | 4.8 mSec | Standard Deviation 16.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 8: Change from baseline | -2.8 mSec | Standard Deviation 15.9 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 12: Change from baseline | -1.7 mSec | Standard Deviation 18.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 16: Change from baseline | 2.6 mSec | Standard Deviation 15.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 12: Change from baseline | -1.9 mSec | Standard Deviation 13.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 16: Change from baseline | -5.6 mSec | Standard Deviation 14.2 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Baseline | 413.8 mSec | Standard Deviation 19.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 4: Change from baseline | -4.2 mSec | Standard Deviation 11.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 8: Change from baseline | -2.7 mSec | Standard Deviation 10.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 2: Change from baseline | -3.5 mSec | Standard Deviation 10.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 8: Change from baseline | 4.0 mSec | Standard Deviation 13.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 12: Change from baseline | -5.1 mSec | Standard Deviation 13.2 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Baseline | 413.2 mSec | Standard Deviation 14.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 4: Change from baseline | 2.1 mSec | Standard Deviation 23.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 2: Change from baseline | 3.4 mSec | Standard Deviation 13.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 16: Change from baseline | 1.5 mSec | Standard Deviation 14.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 8: Change from baseline | -2.6 mSec | Standard Deviation 28.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 2: Change from baseline | -4.8 mSec | Standard Deviation 29.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 4: Change from baseline | -3.5 mSec | Standard Deviation 24.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 16: Change from baseline | -4.8 mSec | Standard Deviation 32.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 12: Change from baseline | -5.1 mSec | Standard Deviation 30.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Baseline | 413.1 mSec | Standard Deviation 30.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 12: Change from baseline | 1.1 mSec | Standard Deviation 14.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 4: Change from baseline | 0.4 mSec | Standard Deviation 15.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 2: Change from baseline | -2.5 mSec | Standard Deviation 15.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 16: Change from baseline | -1.3 mSec | Standard Deviation 16.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Week 8: Change from baseline | -0.4 mSec | Standard Deviation 16.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) | Baseline | 411.4 mSec | Standard Deviation 18.6 |
Secondary
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR)
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. In categories the number of subjects analyzed (N) for each week is mentioned for each reporting group respectively.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 12: Change from baseline | 25.5 mSec | Standard Deviation 143.4 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 4: Change from baseline | 1.6 mSec | Standard Deviation 82.8 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 16: Change from baseline | -22.4 mSec | Standard Deviation 135.5 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 8: Change from baseline ) | 35.8 mSec | Standard Deviation 108.7 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 2: Change from baseline | 17.3 mSec | Standard Deviation 84.2 |
| Placebo | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Baseline | 913.5 mSec | Standard Deviation 128.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 12: Change from baseline | 18.0 mSec | Standard Deviation 110.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 2: Change from baseline | 23.0 mSec | Standard Deviation 101.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 16: Change from baseline | 2.4 mSec | Standard Deviation 138.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 8: Change from baseline ) | 24.8 mSec | Standard Deviation 104.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 4: Change from baseline | 24.8 mSec | Standard Deviation 101.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Baseline | 891.4 mSec | Standard Deviation 145.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Baseline | 934.3 mSec | Standard Deviation 120.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 2: Change from baseline | -12.6 mSec | Standard Deviation 99.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 8: Change from baseline ) | 19.0 mSec | Standard Deviation 128.6 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 12: Change from baseline | -23.3 mSec | Standard Deviation 105.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 4: Change from baseline | 20.5 mSec | Standard Deviation 108.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 16: Change from baseline | -25.4 mSec | Standard Deviation 149.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Baseline | 927.8 mSec | Standard Deviation 135.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 16: Change from baseline | 5.9 mSec | Standard Deviation 110.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 4: Change from baseline | 27.3 mSec | Standard Deviation 92.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 8: Change from baseline ) | 22.3 mSec | Standard Deviation 109.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 2: Change from baseline | 27.3 mSec | Standard Deviation 94.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 12: Change from baseline | 27.2 mSec | Standard Deviation 95.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 12: Change from baseline | -1.4 mSec | Standard Deviation 107.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 4: Change from baseline | 4.5 mSec | Standard Deviation 108 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 8: Change from baseline ) | -22.6 mSec | Standard Deviation 90.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 2: Change from baseline | -2.6 mSec | Standard Deviation 137.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Week 16: Change from baseline | -8.0 mSec | Standard Deviation 110.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) | Baseline | 935.9 mSec | Standard Deviation 151.2 |
Secondary
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16
The BDI-II is a 21-item questionnaire assessing the intensity of depressive symptoms over the past 2 weeks. It is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Participants rated each item on a scale of 0 to 3 to give a total score ranging from 0 to 63, with a higher score suggesting more severe depressive symptoms.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 11.18 Units on scale | Standard Deviation 8.74 |
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.90 Units on scale | Standard Deviation 5.29 |
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.55 Units on scale | Standard Deviation 5.14 |
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -2.24 Units on scale | Standard Deviation 5.26 |
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.30 Units on scale | Standard Deviation 7.22 |
| Placebo | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -2.43 Units on scale | Standard Deviation 6.08 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -5.00 Units on scale | Standard Deviation 3.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -5.10 Units on scale | Standard Deviation 11.62 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 14.29 Units on scale | Standard Deviation 11.36 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -4.23 Units on scale | Standard Deviation 9.82 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -5.32 Units on scale | Standard Deviation 10.13 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -2.23 Units on scale | Standard Deviation 9.27 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -2.00 Units on scale | Standard Deviation 8.22 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.69 Units on scale | Standard Deviation 7.65 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 10.47 Units on scale | Standard Deviation 7.01 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -2.35 Units on scale | Standard Deviation 5.16 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -3.06 Units on scale | Standard Deviation 7.34 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.75 Units on scale | Standard Deviation 6.71 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -4.73 Units on scale | Standard Deviation 6.34 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -3.65 Units on scale | Standard Deviation 6.95 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -4.08 Units on scale | Standard Deviation 6.39 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -4.04 Units on scale | Standard Deviation 6.12 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -4.29 Units on scale | Standard Deviation 6.56 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 9.92 Units on scale | Standard Deviation 8.62 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -5.73 Units on scale | Standard Deviation 7.39 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -4.13 Units on scale | Standard Deviation 6.63 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -2.71 Units on scale | Standard Deviation 6.08 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -2.36 Units on scale | Standard Deviation 8.05 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -5.51 Units on scale | Standard Deviation 7.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 11.48 Units on scale | Standard Deviation 9.3 |
Secondary
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16
The Columbia Suicide Severity Rating Scale (C-SSRS) is a rating scale created to evaluate suicidality in adults and children over the age of 12. It rates an individual's degree of suicidal ideation on a scale, ranging from wish to be dead to active suicidal ideation with specific plan and intent. The version used was the eC-SSRS, which is a subject-reported version of the scale. Shifts from baseline versus post-baseline to demonstrate changes in categories (cat) were reported using cat 1 (No Suicidal Ideation or Behaviour), cat 2 (Suicidal Ideation) and cat 3 (Suicidal Behaviour).
Time frame: Baseline to Weeks 4, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 1 | 6 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 1 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 2 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 2 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 1 | 7 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 1 | 5 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 1 | 34 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 2 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 1 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 1 | 34 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 3 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 1 | 1 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 2 | 0 Participants |
| Placebo | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 1 | 33 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 1 | 14 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 1 | 15 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 2 | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 2 | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 1 | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 1 | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 3 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 2 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 1 | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 1 | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 1 | 14 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 1 | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 1 | 7 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 1 | 12 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 1 | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 1 | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 1 | 12 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 1 | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 1 | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 1 | 13 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 1 | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 3 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 1 | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 1 | 40 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 1 | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 1 | 4 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 1 | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 1 | 38 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 1 | 40 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 1 | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 1 | 4 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 1 | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 2 | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 3 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 1 | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 3 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 3 to cat 1 | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 1 | 38 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 1 | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 1 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 2 to cat 1 | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 1 | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 2 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 12: shift from cat 1 to cat 1 | 33 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 1 | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 3 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 4: shift from cat 3 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 2 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 | Week 16: shift from cat 1 to cat 1 | 33 Participants |
Secondary
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI uses 19 individual items to generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each scored 0 (no difficulty) to 3 (severe difficulty). The sum of scores for these seven components yields one global score (range 0 to 21). Higher scores indicated worse sleep quality.
Time frame: From baseline to Weeks 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data. Some participants either had missing value at baseline or missing value at a specific assessment week, so the change from baseline value cannot be obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -1.15 Units on scale | Standard Deviation 2.95 |
| Placebo | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Baseline | 10.80 Units on scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -1.85 Units on scale | Standard Deviation 2.46 |
| Placebo | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -0.63 Units on scale | Standard Deviation 2.02 |
| Placebo | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -1.36 Units on scale | Standard Deviation 2.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -2.47 Units on scale | Standard Deviation 3.82 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -2.39 Units on scale | Standard Deviation 3.63 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -1.87 Units on scale | Standard Deviation 2.93 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -2.10 Units on scale | Standard Deviation 3.53 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Baseline | 11.94 Units on scale | Standard Deviation 3.11 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -2.38 Units on scale | Standard Deviation 3.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Baseline | 11.35 Units on scale | Standard Deviation 3.66 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -1.94 Units on scale | Standard Deviation 2.68 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -2.81 Units on scale | Standard Deviation 2.97 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -1.38 Units on scale | Standard Deviation 3.26 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -2.24 Units on scale | Standard Deviation 3.12 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Baseline | 10.80 Units on scale | Standard Deviation 3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -3.39 Units on scale | Standard Deviation 3.12 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -3.00 Units on scale | Standard Deviation 3.23 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -2.70 Units on scale | Standard Deviation 3.11 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -3.14 Units on scale | Standard Deviation 3.37 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -3.54 Units on scale | Standard Deviation 4.12 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Baseline | 11.44 Units on scale | Standard Deviation 3.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -1.79 Units on scale | Standard Deviation 2.69 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -2.80 Units on scale | Standard Deviation 2.84 |
Secondary
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16
The HFRDIS is a 10-item, self-report questionnaire assessing the impact of hot flushes on a woman's life during the past week. For each of the 10 items, participants rated how much hot flushes had interfered with that aspect of their life on a scale of 0 (not at all) to 10 (very much so). The total score was calculated by adding the scores for all 10 items. Higher scores indicated greater interference.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 52.93 Units on scale | Standard Deviation 18.4 |
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -4.00 Units on scale | Standard Deviation 20.28 |
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -9.98 Units on scale | Standard Deviation 20.84 |
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -15.48 Units on scale | Standard Deviation 21.07 |
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from | -19.37 Units on scale | Standard Deviation 20.2 |
| Placebo | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -15.22 Units on scale | Standard Deviation 21.72 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from | -21.30 Units on scale | Standard Deviation 22.89 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -10.73 Units on scale | Standard Deviation 24.87 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 52.74 Units on scale | Standard Deviation 20.33 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -13.00 Units on scale | Standard Deviation 22.53 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -16.26 Units on scale | Standard Deviation 23.71 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -5.39 Units on scale | Standard Deviation 21.99 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -17.88 Units on scale | Standard Deviation 27.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from | -15.56 Units on scale | Standard Deviation 28.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 50.29 Units on scale | Standard Deviation 21.45 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -15.06 Units on scale | Standard Deviation 24.02 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -11.12 Units on scale | Standard Deviation 28.14 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -16.69 Units on scale | Standard Deviation 24.15 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -26.39 Units on scale | Standard Deviation 24.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -13.75 Units on scale | Standard Deviation 29.66 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -23.04 Units on scale | Standard Deviation 28.32 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -19.16 Units on scale | Standard Deviation 22.43 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from | -28.33 Units on scale | Standard Deviation 25.36 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 53.86 Units on scale | Standard Deviation 23.42 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from | -27.83 Units on scale | Standard Deviation 24.64 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -18.44 Units on scale | Standard Deviation 23.37 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -10.90 Units on scale | Standard Deviation 21.31 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -12.07 Units on scale | Standard Deviation 25.94 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -24.09 Units on scale | Standard Deviation 25.51 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 | Baseline | 55.36 Units on scale | Standard Deviation 19.71 |
Secondary
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16
The ISI is a brief self-report questionnaire assessing the nature, severity, and impact of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Participants rated each item on a scale of 0 to 4, yielding a total score ranging from 0 to 28. The total score was calculated by adding the scores for all seven items. Higher scores indicated severe insomnia.
Time frame: From baseline to Weeks 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data. Some participants either had missing value at baseline or missing value at a specific assessment week, so the change from baseline value cannot be obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 12: Change from Baseline | -1.95 Units on scale | Standard Deviation 4.7 |
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Baseline | 12.43 Units on scale | Standard Deviation 5.09 |
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 16: Change from Baseline | -2.65 Units on scale | Standard Deviation 4.32 |
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 4: Change from Baseline | -1.60 Units on scale | Standard Deviation 2.98 |
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 8: Change from Baseline | -1.51 Units on scale | Standard Deviation 3.64 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 12: Change from Baseline | -3.80 Units on scale | Standard Deviation 5.45 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 8: Change from Baseline | -3.74 Units on scale | Standard Deviation 5.63 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 4: Change from Baseline | -2.74 Units on scale | Standard Deviation 4.91 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 16: Change from Baseline | -3.73 Units on scale | Standard Deviation 6.02 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Baseline | 13.23 Units on scale | Standard Deviation 5.36 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 8: Change from Baseline | -4.44 Units on scale | Standard Deviation 6.17 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Baseline | 13.24 Units on scale | Standard Deviation 8.04 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 4: Change from Baseline | -3.65 Units on scale | Standard Deviation 6.03 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 12: Change from Baseline | -5.81 Units on scale | Standard Deviation 5.86 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 16: Change from Baseline | -3.00 Units on scale | Standard Deviation 3.72 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 16: Change from Baseline | -4.34 Units on scale | Standard Deviation 5.58 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Baseline | 12.63 Units on scale | Standard Deviation 5.66 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 12: Change from Baseline | -6.12 Units on scale | Standard Deviation 5.41 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 8: Change from Baseline | -6.20 Units on scale | Standard Deviation 4.93 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 4: Change from Baseline | -5.14 Units on scale | Standard Deviation 5.51 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 8: Change from Baseline | -5.72 Units on scale | Standard Deviation 5.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 12: Change from Baseline | -7.39 Units on scale | Standard Deviation 5.82 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Baseline | 13.74 Units on scale | Standard Deviation 5.89 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 16: Change from Baseline | -4.00 Units on scale | Standard Deviation 5.49 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 | Week 4: Change from Baseline | -5.42 Units on scale | Standard Deviation 5.42 |
Secondary
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16
The MenQoL-I is a validated questionnaire used to measure condition-specific quality of life in menopausal women. It is composed of 32 items across four domains (physical, vasomotor, psychosocial and sexual). For each item, participants recorded whether they had experienced the problem in the past month, and if so, they rated how bothered they were by the problem on a scale of 0 (not at all bothered) to 6 (extremely bothered). The item scores were converted to a score ranging from 1 to 8. Domain scores are calculated by averaging the converted individual item scores (range 1-8) related to the respective domain. (Domains: Vasomotor - items 1 to 3, Psychosocial - items 4 to 10, Physical- items 11- to 26, Sexual - items 27 to 29). For a MENQOL total score the aggregated mean of the mean domain scores is calculated. Higher scores indicate greater bother.
Time frame: From baseline to Weeks 4, 8, 12 and 16;
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -0.70 Units on scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Baseline | 4.00 Units on scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -0.68 Units on scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -0.33 Units on scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -0.62 Units on scale | Standard Deviation 1.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -0.81 Units on scale | Standard Deviation 1.44 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -0.87 Units on scale | Standard Deviation 1.25 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -0.62 Units on scale | Standard Deviation 1.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -0.76 Units on scale | Standard Deviation 1.33 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Baseline | 4.38 Units on scale | Standard Deviation 1.16 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -0.91 Units on scale | Standard Deviation 1.06 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Baseline | 4.47 Units on scale | Standard Deviation 1.25 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -0.56 Units on scale | Standard Deviation 0.87 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -1.09 Units on scale | Standard Deviation 0.76 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -0.69 Units on scale | Standard Deviation 0.93 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -1.18 Units on scale | Standard Deviation 1.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Baseline | 4.17 Units on scale | Standard Deviation 1.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -1.54 Units on scale | Standard Deviation 1.34 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -1.45 Units on scale | Standard Deviation 1.18 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -1.29 Units on scale | Standard Deviation 1.14 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 8: Change from baseline | -1.50 Units on scale | Standard Deviation 0.99 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 12: Change from baseline | -1.72 Units on scale | Standard Deviation 1.32 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Baseline | 4.50 Units on scale | Standard Deviation 1.23 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 16: Change from baseline | -1.00 Units on scale | Standard Deviation 1.36 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 | Week 4: Change from baseline | -1.13 Units on scale | Standard Deviation 1.09 |
Secondary
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Baseline | 28.59 kg/m^2 | Standard Deviation 3.81 |
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.07 kg/m^2 | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.07 kg/m^2 | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.04 kg/m^2 | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.03 kg/m^2 | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.04 kg/m^2 | Standard Deviation 0.96 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.21 kg/m^2 | Standard Deviation 0.87 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.13 kg/m^2 | Standard Deviation 1.01 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Baseline | 27.69 kg/m^2 | Standard Deviation 4.97 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.02 kg/m^2 | Standard Deviation 0.42 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.09 kg/m^2 | Standard Deviation 0.59 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.11 kg/m^2 | Standard Deviation 0.39 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.04 kg/m^2 | Standard Deviation 0.69 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.05 kg/m^2 | Standard Deviation 0.79 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Baseline | 29.81 kg/m^2 | Standard Deviation 4.93 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.06 kg/m^2 | Standard Deviation 0.75 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.06 kg/m^2 | Standard Deviation 0.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.04 kg/m^2 | Standard Deviation 1.01 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.06 kg/m^2 | Standard Deviation 0.66 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.04 kg/m^2 | Standard Deviation 0.45 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.11 kg/m^2 | Standard Deviation 0.49 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.07 kg/m^2 | Standard Deviation 0.79 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.02 kg/m^2 | Standard Deviation 0.73 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Baseline | 27.26 kg/m^2 | Standard Deviation 4.85 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.18 kg/m^2 | Standard Deviation 0.99 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.00 kg/m^2 | Standard Deviation 0.53 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.01 kg/m^2 | Standard Deviation 0.33 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.13 kg/m^2 | Standard Deviation 1.07 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.09 kg/m^2 | Standard Deviation 0.88 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 | Baseline | 27.72 kg/m^2 | Standard Deviation 4.74 |
Secondary
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 80.1 mmHg | Standard Deviation 8 |
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.7 mmHg | Standard Deviation 6.6 |
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.2 mmHg | Standard Deviation 7.4 |
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.2 mmHg | Standard Deviation 6.7 |
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.5 mmHg | Standard Deviation 9.6 |
| Placebo | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 1.6 mmHg | Standard Deviation 7.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -2.8 mmHg | Standard Deviation 9.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.2 mmHg | Standard Deviation 8.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 78.7 mmHg | Standard Deviation 8.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 1.2 mmHg | Standard Deviation 7.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.5 mmHg | Standard Deviation 6.8 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.1 mmHg | Standard Deviation 8.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -3.6 mmHg | Standard Deviation 6.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -2.2 mmHg | Standard Deviation 7.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 79.9 mmHg | Standard Deviation 9.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -2.1 mmHg | Standard Deviation 6.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.8 mmHg | Standard Deviation 8.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -3.8 mmHg | Standard Deviation 9.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.6 mmHg | Standard Deviation 8.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -3.1 mmHg | Standard Deviation 7.6 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -2.8 mmHg | Standard Deviation 9.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.9 mmHg | Standard Deviation 9.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.8 mmHg | Standard Deviation 10.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 78.1 mmHg | Standard Deviation 7.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.0 mmHg | Standard Deviation 9.3 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -2.3 mmHg | Standard Deviation 8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.4 mmHg | Standard Deviation 7.6 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.6 mmHg | Standard Deviation 7.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.6 mmHg | Standard Deviation 7.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 78.7 mmHg | Standard Deviation 10.1 |
Secondary
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Baseline | 69.7 beats/min | Standard Deviation 7.8 |
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.1 beats/min | Standard Deviation 8.1 |
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.6 beats/min | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.4 beats/min | Standard Deviation 7.7 |
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.1 beats/min | Standard Deviation 9.2 |
| Placebo | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 3.2 beats/min | Standard Deviation 10.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.3 beats/min | Standard Deviation 8.4 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 3.3 beats/min | Standard Deviation 10.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Baseline | 71.4 beats/min | Standard Deviation 10.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.5 beats/min | Standard Deviation 7.6 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.5 beats/min | Standard Deviation 8.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.3 beats/min | Standard Deviation 7.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -3.1 beats/min | Standard Deviation 9.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.9 beats/min | Standard Deviation 8.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Baseline | 70.6 beats/min | Standard Deviation 8.7 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -2.8 beats/min | Standard Deviation 8.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.7 beats/min | Standard Deviation 9.9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.0 beats/min | Standard Deviation 11.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -2.8 beats/min | Standard Deviation 7.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -3.1 beats/min | Standard Deviation 9.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.8 beats/min | Standard Deviation 6.4 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.7 beats/min | Standard Deviation 8.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.4 beats/min | Standard Deviation 8.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Baseline | 70.1 beats/min | Standard Deviation 10.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.9 beats/min | Standard Deviation 7.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.9 beats/min | Standard Deviation 7.7 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 2.1 beats/min | Standard Deviation 9.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.3 beats/min | Standard Deviation 8.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.3 beats/min | Standard Deviation 8.1 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 | Baseline | 69.7 beats/min | Standard Deviation 10.2 |
Secondary
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 123.2 mmHg | Standard Deviation 10.4 |
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.3 mmHg | Standard Deviation 12.5 |
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 1.7 mmHg | Standard Deviation 12.4 |
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.5 mmHg | Standard Deviation 10.8 |
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.6 mmHg | Standard Deviation 12.2 |
| Placebo | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 3.8 mmHg | Standard Deviation 13.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -2.1 mmHg | Standard Deviation 10.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.9 mmHg | Standard Deviation 11.7 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 124.2 mmHg | Standard Deviation 10.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.1 mmHg | Standard Deviation 11.9 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.5 mmHg | Standard Deviation 12.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.2 mmHg | Standard Deviation 9 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -2.1 mmHg | Standard Deviation 10.1 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -5.9 mmHg | Standard Deviation 11.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 128.9 mmHg | Standard Deviation 9.8 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -3.1 mmHg | Standard Deviation 9.4 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.5 mmHg | Standard Deviation 12.5 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -6.4 mmHg | Standard Deviation 11.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.3 mmHg | Standard Deviation 10 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -2.9 mmHg | Standard Deviation 9.3 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -4.7 mmHg | Standard Deviation 10.7 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.4 mmHg | Standard Deviation 10.8 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.1 mmHg | Standard Deviation 10.2 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 124.6 mmHg | Standard Deviation 10.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.3 mmHg | Standard Deviation 12.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.3 mmHg | Standard Deviation 10.8 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.8 mmHg | Standard Deviation 9.2 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 2.1 mmHg | Standard Deviation 9.4 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -3.8 mmHg | Standard Deviation 10.5 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 | Baseline | 124.0 mmHg | Standard Deviation 12.9 |
Secondary
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Baseline | 36.69 Celsius (C) | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.09 Celsius (C) | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.15 Celsius (C) | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.09 Celsius (C) | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.12 Celsius (C) | Standard Deviation 0.44 |
| Placebo | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.07 Celsius (C) | Standard Deviation 0.5 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.12 Celsius (C) | Standard Deviation 0.31 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.03 Celsius (C) | Standard Deviation 0.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Baseline | 36.62 Celsius (C) | Standard Deviation 0.32 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.06 Celsius (C) | Standard Deviation 0.34 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.01 Celsius (C) | Standard Deviation 0.35 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.04 Celsius (C) | Standard Deviation 0.28 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.00 Celsius (C) | Standard Deviation 0.31 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.03 Celsius (C) | Standard Deviation 0.38 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Baseline | 36.73 Celsius (C) | Standard Deviation 0.3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.01 Celsius (C) | Standard Deviation 0.41 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.04 Celsius (C) | Standard Deviation 0.26 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.04 Celsius (C) | Standard Deviation 0.32 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.11 Celsius (C) | Standard Deviation 0.49 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.12 Celsius (C) | Standard Deviation 0.5 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.12 Celsius (C) | Standard Deviation 0.46 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.08 Celsius (C) | Standard Deviation 0.41 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.04 Celsius (C) | Standard Deviation 0.46 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Baseline | 36.52 Celsius (C) | Standard Deviation 0.46 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.08 Celsius (C) | Standard Deviation 0.36 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.06 Celsius (C) | Standard Deviation 0.32 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.01 Celsius (C) | Standard Deviation 0.43 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.09 Celsius (C) | Standard Deviation 0.41 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.01 Celsius (C) | Standard Deviation 0.42 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 | Baseline | 36.68 Celsius (C) | Standard Deviation 0.39 |
Secondary
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Baseline | 95.47 cm | Standard Deviation 11.69 |
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.26 cm | Standard Deviation 3.99 |
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.17 cm | Standard Deviation 4.99 |
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.14 cm | Standard Deviation 4.45 |
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.72 cm | Standard Deviation 5.25 |
| Placebo | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.80 cm | Standard Deviation 5.46 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.16 cm | Standard Deviation 4.87 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.99 cm | Standard Deviation 5.18 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Baseline | 93.61 cm | Standard Deviation 13.1 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.07 cm | Standard Deviation 4.23 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.11 cm | Standard Deviation 4.3 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.79 cm | Standard Deviation 3.55 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.04 cm | Standard Deviation 2.77 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.60 cm | Standard Deviation 2.81 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Baseline | 97.59 cm | Standard Deviation 13.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.26 cm | Standard Deviation 3 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.91 cm | Standard Deviation 2.15 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 4.33 cm | Standard Deviation 12.9 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.76 cm | Standard Deviation 4.1 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.13 cm | Standard Deviation 3.72 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.05 cm | Standard Deviation 3.84 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.02 cm | Standard Deviation 4.58 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.25 cm | Standard Deviation 3.97 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Baseline | 91.12 cm | Standard Deviation 13.03 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.39 cm | Standard Deviation 4.42 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.09 cm | Standard Deviation 3.97 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.18 cm | Standard Deviation 3.9 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.24 cm | Standard Deviation 4.41 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.08 cm | Standard Deviation 4.71 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 | Baseline | 92.42 cm | Standard Deviation 12.36 |
Secondary
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16
Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Baseline | 75.85 Kilogram (Kg) | Standard Deviation 13.13 |
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.20 Kilogram (Kg) | Standard Deviation 1.07 |
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.23 Kilogram (Kg) | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.16 Kilogram (Kg) | Standard Deviation 1.98 |
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.02 Kilogram (Kg) | Standard Deviation 2.34 |
| Placebo | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.17 Kilogram (Kg) | Standard Deviation 2.48 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | 0.58 Kilogram (Kg) | Standard Deviation 2.46 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.39 Kilogram (Kg) | Standard Deviation 2.81 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Baseline | 72.65 Kilogram (Kg) | Standard Deviation 14.76 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.08 Kilogram (Kg) | Standard Deviation 1.11 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | 0.26 Kilogram (Kg) | Standard Deviation 1.59 |
| 40 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.30 Kilogram (Kg) | Standard Deviation 1.03 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.11 Kilogram (Kg) | Standard Deviation 1.79 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.14 Kilogram (Kg) | Standard Deviation 2.03 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Baseline | 78.14 Kilogram (Kg) | Standard Deviation 15.75 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.12 Kilogram (Kg) | Standard Deviation 1.88 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.13 Kilogram (Kg) | Standard Deviation 1.32 |
| 80 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.13 Kilogram (Kg) | Standard Deviation 2.59 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.18 Kilogram (Kg) | Standard Deviation 1.78 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.13 Kilogram (Kg) | Standard Deviation 1.19 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.31 Kilogram (Kg) | Standard Deviation 1.26 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.20 Kilogram (Kg) | Standard Deviation 2.13 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.08 Kilogram (Kg) | Standard Deviation 1.93 |
| 120 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Baseline | 72.36 Kilogram (Kg) | Standard Deviation 15.26 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.48 Kilogram (Kg) | Standard Deviation 2.62 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 4: Change from baseline | 0.00 Kilogram (Kg) | Standard Deviation 1.35 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 2: Change from baseline | 0.04 Kilogram (Kg) | Standard Deviation 0.84 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.34 Kilogram (Kg) | Standard Deviation 2.82 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.25 Kilogram (Kg) | Standard Deviation 2.32 |
| 160 mg Elinzanetant (BAY3427080) | Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 | Baseline | 74.11 Kilogram (Kg) | Standard Deviation 15.02 |
Secondary
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16
Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.
Time frame: From baseline to Weeks 1, 2, 8 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -4.33 Hot flushes per day | Standard Deviation 4.79 |
| Placebo | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 11.82 Hot flushes per day | Standard Deviation 4.42 |
| Placebo | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | -3.95 Hot flushes per day | Standard Deviation 4.85 |
| Placebo | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -1.22 Hot flushes per day | Standard Deviation 3.07 |
| Placebo | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -2.19 Hot flushes per day | Standard Deviation 4.01 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -5.72 Hot flushes per day | Standard Deviation 6.18 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -3.03 Hot flushes per day | Standard Deviation 3.95 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -1.61 Hot flushes per day | Standard Deviation 3.05 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | -5.74 Hot flushes per day | Standard Deviation 9.45 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 12.13 Hot flushes per day | Standard Deviation 8.81 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -3.47 Hot flushes per day | Standard Deviation 4.37 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 14.55 Hot flushes per day | Standard Deviation 5.87 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -1.63 Hot flushes per day | Standard Deviation 3.56 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -5.94 Hot flushes per day | Standard Deviation 5.26 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | -2.01 Hot flushes per day | Standard Deviation 4.99 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | -5.95 Hot flushes per day | Standard Deviation 6.95 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 13.54 Hot flushes per day | Standard Deviation 7.17 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -7.84 Hot flushes per day | Standard Deviation 5.95 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -4.58 Hot flushes per day | Standard Deviation 4.7 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -3.22 Hot flushes per day | Standard Deviation 3.43 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -3.78 Hot flushes per day | Standard Deviation 4.48 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -5.58 Hot flushes per day | Standard Deviation 6 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 12.92 Hot flushes per day | Standard Deviation 6.9 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | -2.78 Hot flushes per day | Standard Deviation 6.54 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -3.09 Hot flushes per day | Standard Deviation 3.76 |
Secondary
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16
Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.
Time frame: From baseline to Weeks 1, 2, 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 14.04 Hot flushes per day | Standard Deviation 5.57 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16 | -4.60 Hot flushes per day | Standard Deviation 6.17 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12 | -5.07 Hot flushes per day | Standard Deviation 5.48 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2 | -2.35 Hot flushes per day | Standard Deviation 4.6 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1 | -1.36 Hot flushes per day | Standard Deviation 3.03 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4 | -2.67 Hot flushes per day | Standard Deviation 4.09 |
| Placebo | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8 | -4.74 Hot flushes per day | Standard Deviation 5.57 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8 | -5.65 Hot flushes per day | Standard Deviation 6.55 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4 | -4.11 Hot flushes per day | Standard Deviation 6.31 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1 | -1.72 Hot flushes per day | Standard Deviation 3.27 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 14.19 Hot flushes per day | Standard Deviation 11.01 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12 | -6.50 Hot flushes per day | Standard Deviation 8.67 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2 | -2.99 Hot flushes per day | Standard Deviation 4.9 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16 | -5.83 Hot flushes per day | Standard Deviation 10.86 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4 | -3.45 Hot flushes per day | Standard Deviation 8.54 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 16.55 Hot flushes per day | Standard Deviation 6.89 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1 | -1.33 Hot flushes per day | Standard Deviation 5.68 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2 | -2.74 Hot flushes per day | Standard Deviation 5.97 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8 | -5.45 Hot flushes per day | Standard Deviation 6.56 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12 | -5.11 Hot flushes per day | Standard Deviation 8.41 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16 | -1.76 Hot flushes per day | Standard Deviation 7.5 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2 | -4.57 Hot flushes per day | Standard Deviation 5.48 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8 | -7.96 Hot flushes per day | Standard Deviation 6.16 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1 | -3.30 Hot flushes per day | Standard Deviation 3.99 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16 | -6.19 Hot flushes per day | Standard Deviation 7.68 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12 | -7.94 Hot flushes per day | Standard Deviation 6.74 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 15.39 Hot flushes per day | Standard Deviation 7.91 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4 | -6.70 Hot flushes per day | Standard Deviation 6.16 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2 | -4.43 Hot flushes per day | Standard Deviation 5.68 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16 | -3.11 Hot flushes per day | Standard Deviation 6.71 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12 | -7.47 Hot flushes per day | Standard Deviation 7.13 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8 | -6.03 Hot flushes per day | Standard Deviation 6.43 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1 | -3.69 Hot flushes per day | Standard Deviation 4.81 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 15.78 Hot flushes per day | Standard Deviation 9.62 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4 | -5.79 Hot flushes per day | Standard Deviation 6.09 |
Secondary
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16
Subjects were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, subjects recorded the total number of hot flashes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night. Night-time awakenings secondary to hot flashes corresponded to severe hot flash recorded on the morning diary, and all NTAs corresponded to the data recorded in the Total number of times you woke up last night? field from the eDiary recorded in the morning. Number of NTAs secondary to hot flushes could not be higher than the number of all NTAs.
Time frame: From baseline to Weeks 1, 2, 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.90 Night-time awakenings per day | Standard Deviation 1.64 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.05 Night-time awakenings per day | Standard Deviation 1.19 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.31 Night-time awakenings per day | Standard Deviation 1.39 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.69 Night-time awakenings per day | Standard Deviation 1.03 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.57 Night-time awakenings per day | Standard Deviation 0.96 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.89 Night-time awakenings per day | Standard Deviation 1.08 |
| Placebo | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.09 Night-time awakenings per day | Standard Deviation 1.36 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.50 Night-time awakenings per day | Standard Deviation 1.4 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.91 Night-time awakenings per day | Standard Deviation 1.26 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.52 Night-time awakenings per day | Standard Deviation 1.07 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.41 Night-time awakenings per day | Standard Deviation 1.57 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.63 Night-time awakenings per day | Standard Deviation 1.46 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.75 Night-time awakenings per day | Standard Deviation 1.18 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.29 Night-time awakenings per day | Standard Deviation 1.63 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.33 Night-time awakenings per day | Standard Deviation 2.27 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 4.05 Night-time awakenings per day | Standard Deviation 1.86 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.63 Night-time awakenings per day | Standard Deviation 1.53 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.13 Night-time awakenings per day | Standard Deviation 1.89 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.69 Night-time awakenings per day | Standard Deviation 2.21 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.70 Night-time awakenings per day | Standard Deviation 2.53 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.45 Night-time awakenings per day | Standard Deviation 2.05 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.18 Night-time awakenings per day | Standard Deviation 1.27 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.79 Night-time awakenings per day | Standard Deviation 1.35 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.90 Night-time awakenings per day | Standard Deviation 1.03 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.19 Night-time awakenings per day | Standard Deviation 1.23 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.67 Night-time awakenings per day | Standard Deviation 1.27 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.76 Night-time awakenings per day | Standard Deviation 1.71 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.53 Night-time awakenings per day | Standard Deviation 1.19 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.92 Night-time awakenings per day | Standard Deviation 1.38 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.44 Night-time awakenings per day | Standard Deviation 1.62 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.32 Night-time awakenings per day | Standard Deviation 1.75 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.13 Night-time awakenings per day | Standard Deviation 1.86 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.68 Night-time awakenings per day | Standard Deviation 1.14 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.57 Night-time awakenings per day | Standard Deviation 1.54 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.01 Night-time awakenings per day | Standard Deviation 1.62 |
Secondary
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16
Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).
Time frame: From baseline to Weeks 1, 2, 4, 8, 12 and 16
Population: Participants with available data are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.34 Hot flushes per day | Standard Deviation 0.32 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.21 Hot flushes per day | Standard Deviation 0.49 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.21 Hot flushes per day | Standard Deviation 0.44 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.10 Hot flushes per day | Standard Deviation 0.32 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.04 Hot flushes per day | Standard Deviation 0.23 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.11 Hot flushes per day | Standard Deviation 0.36 |
| Placebo | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.25 Hot flushes per day | Standard Deviation 0.54 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.31 Hot flushes per day | Standard Deviation 0.47 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.21 Hot flushes per day | Standard Deviation 0.47 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.04 Hot flushes per day | Standard Deviation 0.18 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.34 Hot flushes per day | Standard Deviation 0.35 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.35 Hot flushes per day | Standard Deviation 0.57 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.15 Hot flushes per day | Standard Deviation 0.27 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.30 Hot flushes per day | Standard Deviation 0.52 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.27 Hot flushes per day | Standard Deviation 0.49 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.46 Hot flushes per day | Standard Deviation 0.37 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.05 Hot flushes per day | Standard Deviation 0.12 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.25 Hot flushes per day | Standard Deviation 0.52 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.23 Hot flushes per day | Standard Deviation 0.52 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.08 Hot flushes per day | Standard Deviation 0.41 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | 0.05 Hot flushes per day | Standard Deviation 0.34 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.21 Hot flushes per day | Standard Deviation 0.46 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.35 Hot flushes per day | Standard Deviation 0.55 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.09 Hot flushes per day | Standard Deviation 0.25 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.26 Hot flushes per day | Standard Deviation 0.56 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.41 Hot flushes per day | Standard Deviation 0.62 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.38 Hot flushes per day | Standard Deviation 0.34 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.35 Hot flushes per day | Standard Deviation 0.6 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.20 Hot flushes per day | Standard Deviation 0.5 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.24 Hot flushes per day | Standard Deviation 0.54 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -0.52 Hot flushes per day | Standard Deviation 0.79 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.44 Hot flushes per day | Standard Deviation 0.72 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.07 Hot flushes per day | Standard Deviation 0.18 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 2.35 Hot flushes per day | Standard Deviation 0.39 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.34 Hot flushes per day | Standard Deviation 0.63 |
Secondary
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16
Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).
Time frame: From baseline to Weeks 1, 2, 8 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -0.45 Hot flushes per day | Standard Deviation 0.58 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.2 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | 2.15 Hot flushes per day | Standard Deviation 0.65 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -0.24 Hot flushes per day | Standard Deviation 0.3 |
| Placebo | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -0.30 Hot flushes per day | Standard Deviation 0.39 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -0.48 Hot flushes per day | Standard Deviation 0.54 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -0.32 Hot flushes per day | Standard Deviation 0.32 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -0.21 Hot flushes per day | Standard Deviation 0.2 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | 2.03 Hot flushes per day | Standard Deviation 0.56 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 2.51 Hot flushes per day | Standard Deviation 0.26 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -0.42 Hot flushes per day | Standard Deviation 0.58 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 2.63 Hot flushes per day | Standard Deviation 0.24 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -0.22 Hot flushes per day | Standard Deviation 0.21 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -0.40 Hot flushes per day | Standard Deviation 0.61 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | 2.50 Hot flushes per day | Standard Deviation 0.46 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | 2.13 Hot flushes per day | Standard Deviation 0.71 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 2.54 Hot flushes per day | Standard Deviation 0.24 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -0.51 Hot flushes per day | Standard Deviation 0.54 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -0.37 Hot flushes per day | Standard Deviation 0.46 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -0.25 Hot flushes per day | Standard Deviation 0.28 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 2: Change from baseline | -0.40 Hot flushes per day | Standard Deviation 0.55 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 8: Change from baseline | -0.65 Hot flushes per day | Standard Deviation 0.73 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Baseline | 2.55 Hot flushes per day | Standard Deviation 0.26 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 16: Change from baseline | 2.08 Hot flushes per day | Standard Deviation 0.62 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 | Week 1: Change from baseline | -0.26 Hot flushes per day | Standard Deviation 0.26 |
Secondary
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16
Participants were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, participants recorded the total number of hot flushes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night.
Time frame: From baseline to Weeks 1, 2, 4, 8, 12 and 16
Population: Participants with available data are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 3.86 Night-time awakenings per day | Standard Deviation 2.06 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.08 Night-time awakenings per day | Standard Deviation 1.3 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.28 Night-time awakenings per day | Standard Deviation 1.44 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.62 Night-time awakenings per day | Standard Deviation 1.54 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.65 Night-time awakenings per day | Standard Deviation 1.08 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.86 Night-time awakenings per day | Standard Deviation 1.4 |
| Placebo | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -0.99 Night-time awakenings per day | Standard Deviation 1.31 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.66 Night-time awakenings per day | Standard Deviation 1.77 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.05 Night-time awakenings per day | Standard Deviation 1.43 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.70 Night-time awakenings per day | Standard Deviation 1.24 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 3.44 Night-time awakenings per day | Standard Deviation 1.82 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.53 Night-time awakenings per day | Standard Deviation 1.89 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -0.70 Night-time awakenings per day | Standard Deviation 1.2 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.96 Night-time awakenings per day | Standard Deviation 1.91 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -0.99 Night-time awakenings per day | Standard Deviation 2.96 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 5.00 Night-time awakenings per day | Standard Deviation 1.76 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.57 Night-time awakenings per day | Standard Deviation 1.57 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.09 Night-time awakenings per day | Standard Deviation 1.84 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.30 Night-time awakenings per day | Standard Deviation 2.15 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.61 Night-time awakenings per day | Standard Deviation 2.46 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.31 Night-time awakenings per day | Standard Deviation 2.9 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.10 Night-time awakenings per day | Standard Deviation 1.34 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.79 Night-time awakenings per day | Standard Deviation 1.47 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.91 Night-time awakenings per day | Standard Deviation 1.06 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -1.05 Night-time awakenings per day | Standard Deviation 1.3 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.60 Night-time awakenings per day | Standard Deviation 1.38 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 3.80 Night-time awakenings per day | Standard Deviation 2.2 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.49 Night-time awakenings per day | Standard Deviation 1.43 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -1.00 Night-time awakenings per day | Standard Deviation 2.1 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -0.32 Night-time awakenings per day | Standard Deviation 2.1 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -1.40 Night-time awakenings per day | Standard Deviation 2.4 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -1.17 Night-time awakenings per day | Standard Deviation 2.51 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -0.86 Night-time awakenings per day | Standard Deviation 1.93 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 3.85 Night-time awakenings per day | Standard Deviation 2.57 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -1.03 Night-time awakenings per day | Standard Deviation 2.22 |
Secondary
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16
Mean daily Hot Flushes score = Sum of (frequency x severity) filled in the diary during the last 7 days (with at least one available data in the evening and/or morning) divided by 7. Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).
Time frame: From baseline to Weeks 1, 2, 4, 8, 12 and 16
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -11.63 (units on a scale)*(hot flushes per day) | Standard Deviation 12.51 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -3.09 (units on a scale)*(hot flushes per day) | Standard Deviation 8.16 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -12.33 (units on a scale)*(hot flushes per day) | Standard Deviation 11.96 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -10.89 (units on a scale)*(hot flushes per day) | Standard Deviation 13.45 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -5.62 (units on a scale)*(hot flushes per day) | Standard Deviation 11 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -6.62 (units on a scale)*(hot flushes per day) | Standard Deviation 9.79 |
| Placebo | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 32.35 (units on a scale)*(hot flushes per day) | Standard Deviation 12.24 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -4.26 (units on a scale)*(hot flushes per day) | Standard Deviation 7.93 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -10.68 (units on a scale)*(hot flushes per day) | Standard Deviation 15.26 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 32.84 (units on a scale)*(hot flushes per day) | Standard Deviation 24.82 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -7.88 (units on a scale)*(hot flushes per day) | Standard Deviation 10.77 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -14.93 (units on a scale)*(hot flushes per day) | Standard Deviation 25.48 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -14.64 (units on a scale)*(hot flushes per day) | Standard Deviation 16.33 |
| 40 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -16.71 (units on a scale)*(hot flushes per day) | Standard Deviation 20.6 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -4.97 (units on a scale)*(hot flushes per day) | Standard Deviation 14.35 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -4.18 (units on a scale)*(hot flushes per day) | Standard Deviation 11.27 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -14.93 (units on a scale)*(hot flushes per day) | Standard Deviation 16.83 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -16.17 (units on a scale)*(hot flushes per day) | Standard Deviation 15.32 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -11.39 (units on a scale)*(hot flushes per day) | Standard Deviation 18.82 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 40.76 (units on a scale)*(hot flushes per day) | Standard Deviation 17.08 |
| 80 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -9.08 (units on a scale)*(hot flushes per day) | Standard Deviation 13.09 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -11.98 (units on a scale)*(hot flushes per day) | Standard Deviation 12.39 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -15.60 (units on a scale)*(hot flushes per day) | Standard Deviation 19.03 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -8.44 (units on a scale)*(hot flushes per day) | Standard Deviation 8.98 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -20.72 (units on a scale)*(hot flushes per day) | Standard Deviation 17.81 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -17.54 (units on a scale)*(hot flushes per day) | Standard Deviation 15.5 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 36.59 (units on a scale)*(hot flushes per day) | Standard Deviation 19.88 |
| 120 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -20.54 (units on a scale)*(hot flushes per day) | Standard Deviation 15.8 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 16: Change from baseline | -7.50 (units on a scale)*(hot flushes per day) | Standard Deviation 16.55 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Baseline | 35.73 (units on a scale)*(hot flushes per day) | Standard Deviation 19.75 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 1: Change from baseline | -8.67 (units on a scale)*(hot flushes per day) | Standard Deviation 10.53 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 2: Change from baseline | -10.51 (units on a scale)*(hot flushes per day) | Standard Deviation 12.47 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 4: Change from baseline | -14.20 (units on a scale)*(hot flushes per day) | Standard Deviation 14.3 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 12: Change from baseline | -17.70 (units on a scale)*(hot flushes per day) | Standard Deviation 15.38 |
| 160 mg Elinzanetant (BAY3427080) | Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 | Week 8: Change from baseline | -14.89 (units on a scale)*(hot flushes per day) | Standard Deviation 15.36 |
Secondary
Nature and Severity of Adverse Events
A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment. Safety Analysis Set.
Time frame: Up to Week 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Nature and Severity of Adverse Events | Number of Serious TEAEs | 2 Participants |
| Placebo | Nature and Severity of Adverse Events | Number of TEAEs leading to death | 0 Participants |
| Placebo | Nature and Severity of Adverse Events | Number of TEAEs | 28 Participants |
| Placebo | Nature and Severity of Adverse Events | Number of TEAEs related to IMP | 7 Participants |
| Placebo | Nature and Severity of Adverse Events | Number of Severe TEAEs | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs related to IMP | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Serious TEAEs | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Severe TEAEs | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs leading to death | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs related to IMP | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs | 14 Participants |
| 80 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Severe TEAEs | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs leading to death | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Serious TEAEs | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs leading to death | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Serious TEAEs | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs related to IMP | 8 Participants |
| 120 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs | 34 Participants |
| 120 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Severe TEAEs | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs related to IMP | 12 Participants |
| 160 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs | 38 Participants |
| 160 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Severe TEAEs | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of Serious TEAEs | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Nature and Severity of Adverse Events | Number of TEAEs leading to death | 0 Participants |
Secondary
Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12
The percent change from baseline at a visit Week 12 was calculated. Percent change = (change from baseline in mean daily frequency of moderate and severe hot flushes from baseline to Week 12 / Mean daily frequency of moderate and severe hot flushes at baseline) \* 100. A participant was considered as a responder with a reduction of ≥50% (or ≥80%) if the percent change was ≤-50 (or ≤-80).
Time frame: Week 12
Population: Participants in full analysis set (FAS) with evaluable data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | Yes | 17 Participants |
| Placebo | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | No | 27 Participants |
| Placebo | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | Yes | 8 Participants |
| Placebo | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | No | 36 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | Yes | 20 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | No | 24 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | No | 10 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | Yes | 6 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | No | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | No | 11 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | Yes | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | Yes | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | Yes | 32 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | No | 19 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | No | 35 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | Yes | 16 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | No | 25 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >=80% reduction | Yes | 18 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | No | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 | >= 50% reduction | Yes | 30 Participants |
Secondary
Number of Subjects Used Concomitant Medications
A concomitant medication is defined as any medication used on or after date and time of first randomised treatment. All concomitant medications taken during the study were recorded in the eCRF. Any medication that was not specifically prohibited was allowed. (1) Antidiarrheals, intestinal antiinflammatory/antiinfective agents.
Time frame: Up to Week 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects Used Concomitant Medications | Corticosteroids for systemic use | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antivirals for systemic use | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antidiarrheals, intestinal agents (1) | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antithrombotic agents | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Gynecological antiinfectives and antiseptics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Urologicals | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Ophthalmologicals | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Beta blocking agents | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Nasal preparations | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs for treatment of bone diseases | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs used in diabetes | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Calcium channel blockers | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Mineral supplements | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Diuretics | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs for acid related disorders | 13 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antianemic preparations | 5 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Muscle relaxants | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Bile and liver therapy | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antipsoriatics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antipruritics, incl. antihistamines, anesthetics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Psychoanaleptics | 6 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antiinflammatory and antirheumatic products | 14 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antiprotozoals | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antihypertensives | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antihemorrhagics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Psycholeptics | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antimycotics for systemic use | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antiepileptics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Vaccines | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Throat preparations | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antibacterials for systemic use | 9 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Tonics | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Other alimentary tract and metabolism products | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Anti-acne preparations | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | All other therapeutic products | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Analgesics | 18 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs for obstructive airway diseases | 7 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Stomatological preparations | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Unspecified herbal and traditional medicine | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Other nervous system drugs | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Cough and cold preparations | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Lipid modifying agents | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Other respiratory system products | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Corticosteroids, dermatological preparations | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antiobesity preparations, excl. Diet products | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antifungals for dermatological use | 0 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Agents acting on the renin-angiotensin system | 7 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Vitamins | 14 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Topical products for joint and muscular pain | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | General nutrients | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs for functional gastrointestinal disorders | 3 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Thyroid therapy | 4 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antibiotics,chemotherapeutics (dermatological use) | 1 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antiemetics and antinauseants | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Anesthetics | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Drugs for constipation | 2 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Antihistamines for systemic use | 5 Participants |
| Placebo | Number of Subjects Used Concomitant Medications | Immunosuppressants | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Unspecified herbal and traditional medicine | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Analgesics | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiinflammatory and antirheumatic products | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vitamins | 6 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for acid related disorders | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psychoanaleptics | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psycholeptics | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibacterials for systemic use | 5 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for obstructive airway diseases | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Lipid modifying agents | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Agents acting on the renin-angiotensin system | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Thyroid therapy | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihistamines for systemic use | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antithrombotic agents | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Nasal preparations | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Diuretics | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antianemic preparations | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Mineral supplements | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Calcium channel blockers | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs used in diabetes | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Beta blocking agents | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Ophthalmologicals | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Urologicals | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antidiarrheals, intestinal agents (1) | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antivirals for systemic use | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids for systemic use | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for constipation | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anesthetics | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiemetics and antinauseants | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for functional gastrointestinal disorders | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | General nutrients | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Topical products for joint and muscular pain | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antifungals for dermatological use | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiobesity preparations, excl. Diet products | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids, dermatological preparations | 2 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Cough and cold preparations | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other nervous system drugs | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | All other therapeutic products | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anti-acne preparations | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other alimentary tract and metabolism products | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Throat preparations | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vaccines | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiepileptics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihemorrhagics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihypertensives | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiprotozoals | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipruritics, incl. antihistamines, anesthetics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipsoriatics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Bile and liver therapy | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for treatment of bone diseases | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Gynecological antiinfectives and antiseptics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Immunosuppressants | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other respiratory system products | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Stomatological preparations | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Tonics | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Muscle relaxants | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibiotics,chemotherapeutics (dermatological use) | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antimycotics for systemic use | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiprotozoals | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Thyroid therapy | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Gynecological antiinfectives and antiseptics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other nervous system drugs | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiemetics and antinauseants | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Muscle relaxants | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for obstructive airway diseases | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psychoanaleptics | 4 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Unspecified herbal and traditional medicine | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antivirals for systemic use | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihypertensives | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs used in diabetes | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antimycotics for systemic use | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | All other therapeutic products | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibiotics,chemotherapeutics (dermatological use) | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihemorrhagics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiepileptics | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiinflammatory and antirheumatic products | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anti-acne preparations | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Nasal preparations | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psycholeptics | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibacterials for systemic use | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vaccines | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other alimentary tract and metabolism products | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for functional gastrointestinal disorders | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Throat preparations | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Tonics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vitamins | 6 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Calcium channel blockers | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Urologicals | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other respiratory system products | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | General nutrients | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antidiarrheals, intestinal agents (1) | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Mineral supplements | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Agents acting on the renin-angiotensin system | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for constipation | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Topical products for joint and muscular pain | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihistamines for systemic use | 3 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antianemic preparations | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Diuretics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for treatment of bone diseases | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antifungals for dermatological use | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antithrombotic agents | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Bile and liver therapy | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Immunosuppressants | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Ophthalmologicals | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiobesity preparations, excl. Diet products | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anesthetics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for acid related disorders | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Lipid modifying agents | 4 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Analgesics | 9 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids, dermatological preparations | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids for systemic use | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipsoriatics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipruritics, incl. antihistamines, anesthetics | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Stomatological preparations | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Cough and cold preparations | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Beta blocking agents | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihistamines for systemic use | 6 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antivirals for systemic use | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids for systemic use | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Immunosuppressants | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for constipation | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Thyroid therapy | 7 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anesthetics | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiemetics and antinauseants | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for functional gastrointestinal disorders | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Agents acting on the renin-angiotensin system | 11 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | General nutrients | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other respiratory system products | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Topical products for joint and muscular pain | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antifungals for dermatological use | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Lipid modifying agents | 8 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiinflammatory and antirheumatic products | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiobesity preparations, excl. Diet products | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids, dermatological preparations | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Cough and cold preparations | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for obstructive airway diseases | 4 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Stomatological preparations | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other nervous system drugs | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Unspecified herbal and traditional medicine | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibacterials for systemic use | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | All other therapeutic products | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anti-acne preparations | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other alimentary tract and metabolism products | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Throat preparations | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psycholeptics | 7 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Tonics | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vaccines | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiepileptics | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihemorrhagics | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psychoanaleptics | 10 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihypertensives | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiprotozoals | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Muscle relaxants | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipruritics, incl. antihistamines, anesthetics | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for acid related disorders | 10 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipsoriatics | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Analgesics | 12 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Bile and liver therapy | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antimycotics for systemic use | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Diuretics | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for treatment of bone diseases | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antianemic preparations | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Mineral supplements | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Nasal preparations | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vitamins | 9 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Calcium channel blockers | 6 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs used in diabetes | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Beta blocking agents | 5 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antithrombotic agents | 6 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Gynecological antiinfectives and antiseptics | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Ophthalmologicals | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Urologicals | 3 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antidiarrheals, intestinal agents (1) | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibiotics,chemotherapeutics (dermatological use) | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for obstructive airway diseases | 9 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antithrombotic agents | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipruritics, incl. antihistamines, anesthetics | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiinflammatory and antirheumatic products | 13 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Muscle relaxants | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids, dermatological preparations | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anesthetics | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antipsoriatics | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiobesity preparations, excl. Diet products | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Urologicals | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antifungals for dermatological use | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Beta blocking agents | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Bile and liver therapy | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vitamins | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihistamines for systemic use | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other respiratory system products | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Corticosteroids for systemic use | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Lipid modifying agents | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Immunosuppressants | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Topical products for joint and muscular pain | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antivirals for systemic use | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antianemic preparations | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Nasal preparations | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for treatment of bone diseases | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | General nutrients | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Ophthalmologicals | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Mineral supplements | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psycholeptics | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other alimentary tract and metabolism products | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for constipation | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Throat preparations | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Gynecological antiinfectives and antiseptics | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for functional gastrointestinal disorders | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antimycotics for systemic use | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Thyroid therapy | 5 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Vaccines | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Anti-acne preparations | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Tonics | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Diuretics | 5 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Calcium channel blockers | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiepileptics | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Psychoanaleptics | 9 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Analgesics | 16 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | All other therapeutic products | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibiotics,chemotherapeutics (dermatological use) | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihemorrhagics | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Agents acting on the renin-angiotensin system | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Stomatological preparations | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Unspecified herbal and traditional medicine | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiemetics and antinauseants | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antihypertensives | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antibacterials for systemic use | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Other nervous system drugs | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Cough and cold preparations | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antidiarrheals, intestinal agents (1) | 3 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Antiprotozoals | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs for acid related disorders | 10 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects Used Concomitant Medications | Drugs used in diabetes | 6 Participants |
Secondary
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal clinically significant ECG.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Baseline | 0 Participants |
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 2 | 0 Participants |
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 4 | 0 Participants |
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 8 | 0 Participants |
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 12 | 0 Participants |
| Placebo | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 16 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 12 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 16 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Baseline | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 4 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 8 | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 8 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 12 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Baseline | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 4 | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 2 | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 16 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 8 | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 2 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 4 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 16 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 12 | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Baseline | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 12 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 4 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 2 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 16 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Week 8 | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit | Baseline | 0 Participants |
Secondary
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal not clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal not clinically significant ECG.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Baseline | 9 Participants |
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 2 | 11 Participants |
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 4 | 13 Participants |
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 8 | 15 Participants |
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 12 | 14 Participants |
| Placebo | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 16 | 16 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 12 | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 16 | 4 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Baseline | 7 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 4 | 8 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 8 | 10 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 2 | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 8 | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 12 | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Baseline | 6 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 4 | 6 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 2 | 5 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 16 | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 8 | 21 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 2 | 18 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 4 | 23 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 16 | 20 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 12 | 19 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Baseline | 21 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 12 | 14 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 4 | 17 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 2 | 24 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 16 | 17 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Week 8 | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit | Baseline | 18 Participants |
Secondary
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec
Absolute QTcF values reported.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >450 to <=480 msec | 1 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >450 to <=480 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >480 to <=500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: <=450 msec | 44 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >450 to <=480 msec | 1 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: missing | 3 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >480 to <=500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: <=450 msec | 42 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: <=450 msec | 46 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: missing | 4 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: missing | 3 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: <=450 msec | 44 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >480 to <=500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >450 to <=480 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >450 to <=480 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >480 to <=500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >480 to <=500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: <=450 msec | 44 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >450 to <=480 msec | 1 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: missing | 3 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: missing | 2 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >500 msec | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: <=450 msec | 44 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: missing | 0 Participants |
| Placebo | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >450 to <=480 msec | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >450 to <=480 msec | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >450 to <=480 msec | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >450 to <=480 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >450 to <=480 msec | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >450 to <=480 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: missing | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: missing | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >480 to <=500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: <=450 msec | 30 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >500 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: <=450 msec | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: <=450 msec | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >450 to <=480 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: <=450 msec | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >450 to <=480 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >450 to <=480 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >500 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: <=450 msec | 17 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >450 to <=480 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: missing | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: <=450 msec | 16 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >450 to <=480 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: missing | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: <=450 msec | 15 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >450 to <=480 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >480 to <=500 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: missing | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: <=450 msec | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >500 msec | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: <=450 msec | 50 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: missing | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: <=450 msec | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: missing | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: <=450 msec | 51 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: missing | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: missing | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: <=450 msec | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: <=450 msec | 52 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >480 to <=500 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >450 to <=480 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: missing | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >450 to <=480 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: missing | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >450 to <=480 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: <=450 msec | 50 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: missing | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: <=450 msec | 45 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: >450 to <=480 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >450 to <=480 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: <=450 msec | 50 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 2: missing | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 12: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: missing | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: missing | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: <=450 msec | 44 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Baseline: >450 to <=480 msec | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: missing | 6 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >480 to <=500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 8: <=450 msec | 46 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: >450 to <=480 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 16: >500 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec | Week 4: <=450 msec | 47 Participants |
Secondary
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec
Increase from Baseline overtime was reported.
Time frame: From baseline to Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: missing | 2 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >30 to <=60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >0 to <=30 msec | 23 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >30 to <=60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: <=0 msec | 20 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: missing | 3 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >0 to <=30 msec | 20 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >30 to <=60 msec | 1 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >0 to <=30 msec | 23 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: <=0 msec | 18 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: <=0 msec | 24 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >0 to <=30 msec | 19 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >30 to <=60 msec | 2 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: <=0 msec | 19 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >30 to <=60 msec | 2 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: <=0 msec | 24 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >60 msec | 0 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: missing | 4 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >0 to <=30 msec | 25 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: missing | 3 Participants |
| Placebo | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: missing | 3 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: missing | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >0 to <=30 msec | 10 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: <=0 msec | 20 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >30 to <=60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >0 to <=30 msec | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >0 to <=30 msec | 12 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >30 to <=60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: <=0 msec | 18 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: missing | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: <=0 msec | 21 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: <=0 msec | 20 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: missing | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >30 to <=60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >0 to <=30 msec | 11 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >30 to <=60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >0 to <=30 msec | 15 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >30 to <=60 msec | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: <=0 msec | 15 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: missing | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: <=0 msec | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >0 to <=30 msec | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >30 to <=60 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: <=0 msec | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >0 to <=30 msec | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >30 to <=60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >60 msec | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: missing | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: <=0 msec | 8 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >0 to <=30 msec | 9 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >30 to <=60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: <=0 msec | 10 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >0 to <=30 msec | 6 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >30 to <=60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: missing | 1 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: <=0 msec | 7 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >0 to <=30 msec | 9 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >30 to <=60 msec | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >0 to <=30 msec | 21 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: missing | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >30 to <=60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: <=0 msec | 27 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >30 to <=60 msec | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: missing | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: <=0 msec | 26 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: <=0 msec | 27 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >30 to <=60 msec | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >0 to <=30 msec | 24 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >30 to <=60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >0 to <=30 msec | 24 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: <=0 msec | 29 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >0 to <=30 msec | 26 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: missing | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >30 to <=60 msec | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: missing | 2 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: <=0 msec | 25 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >0 to <=30 msec | 24 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >60 msec | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: missing | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: missing | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >30 to <=60 msec | 2 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: <=0 msec | 22 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: >0 to <=30 msec | 22 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >0 to <=30 msec | 22 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: <=0 msec | 24 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >30 to <=60 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 4: missing | 4 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >30 to <=60 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 12: >60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: missing | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: missing | 7 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >30 to <=60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: <=0 msec | 24 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: >0 to <=30 msec | 22 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >60 msec | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >0 to <=30 msec | 26 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: <=0 msec | 19 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 16: >0 to <=30 msec | 20 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: >30 to <=60 msec | 1 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 8: missing | 6 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec | Week 2: <=0 msec | 29 Participants |
Secondary
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit
All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Normal ECG was decided by investigator. The findings are presented as Normal ECG.
Time frame: At Weeks 2, 4, 8, 12 and 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Baseline | 38 Participants |
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 2 | 33 Participants |
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 4 | 32 Participants |
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 8 | 29 Participants |
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 12 | 30 Participants |
| Placebo | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 16 | 27 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 12 | 22 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 16 | 26 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Baseline | 24 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 4 | 23 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 8 | 21 Participants |
| 40 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 2 | 23 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 8 | 12 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 12 | 11 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Baseline | 11 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 4 | 10 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 2 | 12 Participants |
| 80 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 16 | 14 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 8 | 30 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 2 | 34 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 4 | 28 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 16 | 31 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 12 | 31 Participants |
| 120 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Baseline | 31 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 12 | 31 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 4 | 31 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 2 | 27 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 16 | 28 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Week 8 | 27 Participants |
| 160 mg Elinzanetant (BAY3427080) | Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit | Baseline | 34 Participants |
Secondary
Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12
Blood samples for analysis of plasma elinzanetant concentrations were collected at Weeks 2, 4, 8, and 12. A small number of participants had elinzanetant concentrations below the LOQ for the assay (1.5 ng/mL) at two or more visits (three participants in each of the 40 mg, 120 mg, and 160 mg groups, four in 80 mg group), indicating that these subjects were non compliant with treatment.
Time frame: At Weeks 2, 4, 8 ,12
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 2 | 64.254 ng/ml | Geometric Coefficient of Variation 75.681 |
| Placebo | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 4 | 78.946 ng/ml | Geometric Coefficient of Variation 78.892 |
| Placebo | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 8 | 87.985 ng/ml | Geometric Coefficient of Variation 68.277 |
| Placebo | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 12 | 70.138 ng/ml | Geometric Coefficient of Variation 66.542 |
| 40 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 4 | 118.554 ng/ml | Geometric Coefficient of Variation 175.865 |
| 40 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 8 | 138.795 ng/ml | Geometric Coefficient of Variation 72.619 |
| 40 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 12 | 130.729 ng/ml | Geometric Coefficient of Variation 414.199 |
| 40 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 2 | 157.207 ng/ml | Geometric Coefficient of Variation 93.12 |
| 80 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 8 | 226.121 ng/ml | Geometric Coefficient of Variation 79.171 |
| 80 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 4 | 253.800 ng/ml | Geometric Coefficient of Variation 142.944 |
| 80 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 12 | 197.041 ng/ml | Geometric Coefficient of Variation 231.39 |
| 80 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 2 | 292.929 ng/ml | Geometric Coefficient of Variation 100.381 |
| 120 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 12 | 298.896 ng/ml | Geometric Coefficient of Variation 220.963 |
| 120 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 4 | 398.389 ng/ml | Geometric Coefficient of Variation 91.644 |
| 120 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 2 | 319.552 ng/ml | Geometric Coefficient of Variation 170.571 |
| 120 mg Elinzanetant (BAY3427080) | Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 | Week 8 | 341.673 ng/ml | Geometric Coefficient of Variation 145.535 |
Secondary
Withdrawals Due to an Adverse Event
A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment.
Time frame: Up to Week 16
Population: Participants in safety analysis set (SAF) with evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Withdrawals Due to an Adverse Event | TEAEs leading to treatment discontinuation | 1 Participants |
| Placebo | Withdrawals Due to an Adverse Event | TEAEs leading to study discontinuation | 1 Participants |
| 40 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to treatment discontinuation | 0 Participants |
| 40 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to study discontinuation | 0 Participants |
| 80 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to treatment discontinuation | 2 Participants |
| 80 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to study discontinuation | 1 Participants |
| 120 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to study discontinuation | 0 Participants |
| 120 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to treatment discontinuation | 0 Participants |
| 160 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to treatment discontinuation | 5 Participants |
| 160 mg Elinzanetant (BAY3427080) | Withdrawals Due to an Adverse Event | TEAEs leading to study discontinuation | 4 Participants |