Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
HCRU exacerbations, SGRQ, CXCR2 antagonist, GSK1325756, Danirixin, COPD
Brief summary
Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized, double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the clinical activity and safety of danirixin compared with placebo in participants with COPD. Following baseline assessments collected over a 7 day period participants will be randomized (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram \[mg\], 10 mg, 25 mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for 24 weeks. Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. Follow up will continue up to 28 days post last dose. Approximately 700 participants will be screened with a target of 540 participants completing 24 weeks of treatment and key study assessments.
Interventions
DRUGDanirixin
Danirixin is available as 5, 10, 25, 35 and 50 mg white, film-coated, oval or round shaped tablets for oral administration.
DRUGDanirixin matching placebo
Danirixin matching placebo will be available as white, film-coated, oval or round shaped tablets for oral administration.
DRUGStandard of care
Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) during the study treatment.
DRUGRescue medication
Participants will continue to use rescue medication(s). The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be aged between 40 to 80 years of age inclusive, at the time of signing the informed consent. * Participants who have COPD (post bronchodilator FEV1/FVC ratio \<0.7 and FEV1% predicted \>=40%) based on American Thoracic Society (ATS)/European Respiratory Society (ERS) current guidelines. Participants with a historical diagnosis of asthma may be included so long as they have a current diagnosis of COPD. * History of respiratory symptoms including chronic cough, mucus hypersecretion, and dyspnea on most days for at least the previous 3 months prior to screening. * Participants with a documented history of COPD exacerbation(s) in the 12 months prior to study participation (screening) meeting at least one of the following criteria: \>=2 COPD exacerbations resulting in prescription for antibiotics and/or oral corticosteroids or hospitalization or extended observation in a hospital emergency room or outpatient center; 1 COPD exacerbation resulting in prescription for antibiotics and/or oral corticosteroids of hospitalization or extended observation in a hospital emergency room or outpatient center and a plasma fibrinogen concentration at screening \>=3 grams/liter (300 milligram/deciliter) * Current and former smokers with a cigarette smoking history of \>=10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent). Current smokers are defined as those who are currently smoking cigarettes (i.e. have smoked at least one cigarette daily or most days for the month prior to Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. * Participants must have the ability and willingness to use an electronic diary (log pad) on a daily basis. * Body weight \>=45 kilogram (kg) * Male or female: A male participant must agree to use contraception during the treatment period and for at least 60 hours after the last dose of study treatment, corresponding to approximately 6 half-lives (which is the time needed to eliminate any teratogenic study treatment) and to refrain from donating sperm during this period; A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 60 hours after the last dose of study treatment. * Capable of giving signed informed consent.
Exclusion criteria
* Diagnosis of other clinically relevant lung diseases (other than COPD), e.g. sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis or lung cancer. * Alpha-1-antitrypsin deficiency as the underlying cause of COPD * Pulse oximetry \<88% at rest at screening. Participants should be tested while breathing room air. However, participants living at high altitudes (above 5000 feet or 1500 meters above sea level) who are receiving supplemental oxygen can be included provided they are receiving the equivalent of \<4 liter per minute (L/min) and screening pulse oximetry is measured while on their usual oxygen settings. * Less than 14 days have elapsed from the completion of a course of antibiotics or oral corticosteroids for a recent COPD exacerbation. * A peripheral blood neutrophil count \<1.5 x 10\^9/L. * Diagnosis of pneumonia (chest X-ray or CT confirmed) within the 3 months prior to screening. * Chest x-ray (posterior-anterior with lateral) or CT scan reveals evidence of a clinically significant abnormality not believed to be due to the presence of COPD (historic results up to 1 year prior to screening may be used). For sites in Germany: If a chest x-ray (or CT scan) within 1 year prior to screening is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office of Radiation Protection (BfS). * History or current evidence of other clinically significant medical condition that is uncontrolled on permitted therapies. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through study participation, or that would affect the safety analysis or other analysis if the disease/condition worsened during the study. * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Abnormal and clinically significant 12-lead ECG finding. The investigator will determine the clinical significance of each abnormal ECG finding in relation to the participant's medical history and exclude participants who would be at undue risk by participating in the study. An abnormal and clinically significant finding that would preclude a participant from entering the study is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation with rapid ventricular rate \>120 beats per minute (bpm); sustained or non-sustained ventricular tachycardia; second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator has been implanted); Corrected QT Interval using Fridericia formula (QTcF) \>=500 millisecond (msec) in participants with QRS \<120 msec and QTcF \>=530 msec in participants with QRS \>=120 msec. * Previous lung surgery (e.g. lobectomy, pneumonectomy) or lung volume reduction procedure. * Current or expected chronic use of macrolide antibiotics during the study period for the prevention of COPD exacerbations. Examples of chronic use include, but are not limited to, daily or two to three times per week use for at least 3 months. * Oral or injectable CYP3A4 or breast cancer resistance protein (BRCP) substrates with a narrow therapeutic index (CYP3A4 substrates include, but are not limited to, alfenatil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and theophylline; BRCP substrates include, but are not limited to, topotecan.) The Investigator should consult with the Medical Monitor if necessary. * Current or expected use of phosphodiesterase-4 inhibitors (e.g. roflumilast). Participants currently receiving roflumilast may be included if they are able to discontinue use from 30 days prior to screening through the completion of the follow up visit. * Participation in a previous clinical trial and has received an investigational product within any of the following time periods prior to the first dosing day in the current study: 30 days, 5 half lives, or twice the duration of the biological effect of the investigational product (whichever is longer). * Participation in a previous clinical trial with danirixin within 1 year prior to the first dosing day in the current study * Exposure to more than four investigational products within 1 year prior to the first dosing day in the current study. * Alanine transferase (ALT) \>2x upper limit of normal (ULN); bilirubin \> 1.5xULN (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * A positive test for human immunodeficiency virus (HIV) antibody * A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result within 3 months prior to screening. * Pulmonary rehabilitation: Participants who have taken part in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening or participants who plan to enter the acute phase of a pulmonary rehabilitation program during the study. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. * A history of allergy or hypersensitivity to any of the ingredients in the study treatment. * A known or suspected history of alcohol or drug abuse within the 2 years prior to screening. * Inability to read: in the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials. * Affiliation with the study site: study investigators, sub-investigators, study coordinators, employees of a study investigator, sub-investigator or study site, or immediate family member of any of the above that are involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | Baseline and Month 6 | E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented. |
| Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | Baseline and Month 6 | E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. |
| Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | Baseline and Month 6 | E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. |
| Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | Baseline and Month 6 | E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 196 | AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE. |
| Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Up to Day 196 | Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10\^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10\^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10\^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI. |
| Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Up to Day 196 | Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High =\> 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=\> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low \<0.6x, high \>4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI. |
| Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Up to Day 168 | Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: \<90 to \>160 millimeters of mercury (mmHg) for SBP and \<40 to \>110 mmHg for DBP, \<35 or \>120 beats per minute for heart rate and \<8 or \>30 breaths per minute for respiration rate. Values above and below this range were considered of PCI. |
| Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Baseline and Day 168 | Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Baseline, Days 84 and 168 | The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. |
| Number of SGRQ Responder | Day 84 and Day 168 | A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower. |
| Change From Baseline COPD Assessment Test (CAT) Total Score | Baseline, Days 84 and 168 | The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. |
| Number of CAT Responder | Day 84 and Day 168 | A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower. |
| Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Baseline, Days 84 and 168 | Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. |
| Percent Predicted Normal FEV1 | At Screening | Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition. |
| Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Baseline, Days 84 and 168 | Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. |
| Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | Up to Day 196 | Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room \[ER\] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and \>=2= participants in each treatment group who experienced 2 or more events. |
| Change From Baseline Number of Puffs of Rescue Medication Per Day | Baseline, Months 1, 2, 3, 4, 5 and 6 | The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. |
| Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Days 84 and 168 | The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2. |
| Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168 | Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Days 1 and 168 | Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population. |
| Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Days 1 and 168 | Blood samples were collected from the participants for the analysis of pharmacokinetic parameter. |
| Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Days 1 and 168 | Blood samples were collected from the participants for the analysis of pharmacokinetic parameter. |
| Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Baseline, Days 84 and 168 | Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. |
| Number of Responders E-RS in COPD (E-RS): COPD Total Score | Month 6 | E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline. |
| Number of EXACT Events Per Participant | Up to Day 196 | EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and \>=2= participants in each treatment group who experienced 2 or more events. |
| Time to First EXACT Event | Up to Day 168 | The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1. |
| Severity of EXACT Event | Up to Day 168 | EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. |
| EXACT Event Duration for All Events | Up to Day 168 | EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported. |
| Time to First HCRU-defined COPD Exacerbation | Up to Day 196 | The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1. |
| Time to First Severe HCRU-defined COPD Exacerbation | Up to Day 196 | A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1. |
| HCRU-defined Exacerbation Duration | Up to Day 196 | The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event. |
Countries
Australia, Canada, Germany, Netherlands, Poland, Romania, South Korea, Spain, United States
Participant flow
Recruitment details
This study investigated the dose response and safety of danirixin compared with placebo in Chronic Obstructive Pulmonary Disease (COPD) participants with respiratory symptoms including cough, increased sputum production and dyspnoea.
Pre-assignment details
A total of 614 participants were randomized in this study across 9 countries.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 102 |
| Danirixin 5 mg Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 102 |
| Danirixin 10 mg Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 103 |
| Danirixin 25 mg Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 103 |
| Danirixin 35 mg Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 102 |
| Danirixin 50 mg Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks. | 102 |
| Total | 614 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event, non-fatal | 3 | 1 | 2 | 0 | 2 | 8 |
| Overall Study | Adverse Event, Serious Fatal | 0 | 1 | 1 | 2 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 2 | 1 | 1 | 0 |
| Overall Study | Liver function test abnormality | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 2 | 6 | 6 | 9 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Danirixin 50 mg | Danirixin 35 mg | Danirixin 25 mg | Danirixin 10 mg | Danirixin 5 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 7.31 | 65.9 Years STANDARD_DEVIATION 7.23 | 65.7 Years STANDARD_DEVIATION 6.98 | 65.1 Years STANDARD_DEVIATION 7.58 | 66.3 Years STANDARD_DEVIATION 7.28 | 65.7 Years STANDARD_DEVIATION 7.48 | 66.3 Years STANDARD_DEVIATION 6.79 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 10 Participants | 78 Participants | 17 Participants | 10 Participants | 17 Participants | 18 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 6 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 87 Participants | 526 Participants | 84 Participants | 92 Participants | 86 Participants | 84 Participants | 93 Participants |
| Sex: Female, Male Female | 29 Participants | 202 Participants | 32 Participants | 35 Participants | 38 Participants | 32 Participants | 36 Participants |
| Sex: Female, Male Male | 73 Participants | 412 Participants | 70 Participants | 67 Participants | 65 Participants | 71 Participants | 66 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 102 | 1 / 103 | 2 / 103 | 1 / 102 | 1 / 102 |
| other Total, other adverse events | 20 / 102 | 24 / 102 | 22 / 103 | 31 / 103 | 27 / 102 | 27 / 102 |
| serious Total, serious adverse events | 8 / 102 | 7 / 102 | 13 / 103 | 10 / 103 | 7 / 102 | 11 / 102 |
Outcome results
Primary
Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time frame: Baseline and Month 6
Population: Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.82 Scores on a scale | Standard Deviation 0.202 |
| Danirixin 5 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.69 Scores on a scale | Standard Deviation 0.162 |
| Danirixin 10 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.41 Scores on a scale | Standard Deviation 0.183 |
| Danirixin 25 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.15 Scores on a scale | Standard Deviation 0.148 |
| Danirixin 35 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.10 Scores on a scale | Standard Deviation 0.141 |
| Danirixin 50 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score) | -0.09 Scores on a scale | Standard Deviation 0.158 |
Comparison: 4-parameter Emax model selected.90% CI: [0, 0.42]
Comparison: 4-parameter Emax model90% CI: [0, 0.87]
Comparison: 4-parameter Emax model selected.90% CI: [0.23, 1.08]
Comparison: 4-parameter Emax model selected.90% CI: [0.37, 1.1]
Comparison: 4-parameter Emax model selected.90% CI: [0.4, 1.12]
Primary
Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time frame: Baseline and Month 6
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.36 Scores on a scale | Standard Deviation 0.148 |
| Danirixin 5 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.35 Scores on a scale | Standard Deviation 0.061 |
| Danirixin 10 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.34 Scores on a scale | Standard Deviation 0.062 |
| Danirixin 25 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.34 Scores on a scale | Standard Deviation 0.069 |
| Danirixin 35 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.34 Scores on a scale | Standard Deviation 0.073 |
| Danirixin 50 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score) | -0.34 Scores on a scale | Standard Deviation 0.078 |
Comparison: Log-linear model.90% CI: [-0.21, 0.23]
Comparison: Log-linear model90% CI: [-0.23, 0.25]
Comparison: Log-linear model90% CI: [-0.27, 0.29]
Comparison: Log-linear model90% CI: [-0.28, 0.3]
Comparison: Log-linear model90% CI: [-0.29, 0.31]
Primary
Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time frame: Baseline and Month 6
Population: Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.83 Scores on a scale | Standard Deviation 0.107 |
| Danirixin 5 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.79 Scores on a scale | Standard Deviation 0.09 |
| Danirixin 10 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.67 Scores on a scale | Standard Deviation 0.109 |
| Danirixin 25 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.46 Scores on a scale | Standard Deviation 0.104 |
| Danirixin 35 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.40 Scores on a scale | Standard Deviation 0.088 |
| Danirixin 50 mg | Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score) | -0.37 Scores on a scale | Standard Deviation 0.098 |
Comparison: 4-parameter Emax model selected.90% CI: [0, 0.16]
Comparison: 4-parameter Emax model90% CI: [0, 0.43]
Comparison: 4-parameter Emax model selected.90% CI: [0.04, 0.61]
Comparison: 4-parameter Emax model selected.90% CI: [0.21, 0.64]
Comparison: 4-parameter Emax model selected.90% CI: [0.26, 0.66]
Primary
Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.
Time frame: Baseline and Month 6
Population: Per Protocol Population. Only those participants with data available at the specified data points was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -2.11 Scores on a scale | Standard Deviation 0.345 |
| Danirixin 5 mg | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -1.93 Scores on a scale | Standard Deviation 0.289 |
| Danirixin 10 mg | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -1.47 Scores on a scale | Standard Deviation 0.349 |
| Danirixin 25 mg | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -0.87 Scores on a scale | Standard Deviation 0.286 |
| Danirixin 35 mg | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -0.76 Scores on a scale | Standard Deviation 0.259 |
| Danirixin 50 mg | Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score | -0.71 Scores on a scale | Standard Deviation 0.281 |
Comparison: 4-parameter Emax model selected.90% CI: [0, 0.66]
Comparison: 4-parameter Emax model90% CI: [0, 1.52]
Comparison: 4-parameter Emax model selected.90% CI: [0.43, 1.97]
Comparison: 4-parameter Emax model selected.90% CI: [0.72, 2.03]
Comparison: 4-parameter Emax model selected.90% CI: [0.79, 2.07]
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Time frame: Up to Day 196
Population: Modified Intent-to-Treat (mITT) population. mIIT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 8 Participants |
| Placebo | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 63 Participants |
| Danirixin 5 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 63 Participants |
| Danirixin 5 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 7 Participants |
| Danirixin 10 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 69 Participants |
| Danirixin 10 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 13 Participants |
| Danirixin 25 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 10 Participants |
| Danirixin 25 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 68 Participants |
| Danirixin 35 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 63 Participants |
| Danirixin 35 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 7 Participants |
| Danirixin 50 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 11 Participants |
| Danirixin 50 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Any AE | 71 Participants |
Primary
Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI
Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High =\> 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=\> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low \<0.6x, high \>4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
Time frame: Up to Day 196
Population: mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles)..
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 1 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 99 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 2 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 1 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 98 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 94 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 94 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 1 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 100 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 1 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 100 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 102 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 101 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, No change, n=96, 102, 101, 101, 101, 99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Direct bilirubin,High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, High, n=99, 102, 102, 102, 101, 100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, No change, n=96, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, High, n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, No change, n=96, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Urea, High, n=96, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Glucose, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, High, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, Low, n=96,102,101,101,101,99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, High, n=99, 102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALP, No change,n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, No change, n=96, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | AST, No change,n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Potassium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | ALT, No change,n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Chloride, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Protein, No change, n=99, 102, 102, 102, 101, 100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin, No change, n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | 100 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, No change, n=96,102,101,101,101,99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, Low, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Sodium, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | CO2, Low, n=96,102,101,101,101,99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, No change, n=96,102,101,101,101,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Bilirubin/ALT, High,n=99,102,102,102,101,100 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Creatinine, High, n=96, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI | Calcium, High, n=96,102,101,101,101,99 | 0 Participants |
Primary
Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)
Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10\^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10\^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10\^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
Time frame: Up to Day 196
Population: mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 94 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 3 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 96 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 93 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 97 Participants |
| Placebo | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 101 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 95 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 7 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 100 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 3 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 97 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 96 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 5 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 92 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 3 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 97 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 3 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 8 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 98 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 100 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 2 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 7 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 100 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 93 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 101 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 98 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 3 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 100 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 100 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, No change, n=97,102,101,101,101,99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, No change, n=97,102,101,101,102,99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils,No change,n=97,102,101,101,101,99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, No change,n=97,102,101,101,102,99 | 97 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC,No change,n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | 4 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, No change, n=97,102,101,101,101,99 | 94 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | 2 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Monocytes, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, No change, n=97, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, No change, n=97, 102, 101, 101, 101, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Basophils, High, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, No change, n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hematocrit, No Change, n=97,102,101,101,102,99 | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Platelets, Low, n=97, 102, 101, 101, 101, 99 | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI) | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | 1 Participants |
Primary
Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings
Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.
Time frame: Baseline and Day 168
Population: mITT population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 2 Participants |
| Placebo | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 52 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 1 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 65 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 1 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 68 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 67 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 62 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 3 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Not Clinical significant | 53 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings | Clinical significant | 1 Participants |
Primary
Number of Participants With Worst Case Vital Signs Parameter Results by PCI
Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: \<90 to \>160 millimeters of mercury (mmHg) for SBP and \<40 to \>110 mmHg for DBP, \<35 or \>120 beats per minute for heart rate and \<8 or \>30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.
Time frame: Up to Day 168
Population: mITT population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 96 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 93 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 96 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 96 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 0 Participants |
| Placebo | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 3 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 10 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 102 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 92 Participants |
| Danirixin 5 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 102 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 2 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 95 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 99 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 101 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Danirixin 10 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 6 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 98 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 3 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 101 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 100 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 1 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 0 Participants |
| Danirixin 25 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 98 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 102 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 4 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 0 Participants |
| Danirixin 35 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, No change | 94 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, Low | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, No change | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, High | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, Low | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, High | 4 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, Low | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Respiratory rate, No change | 98 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, High | 0 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | Pulse rate, High | 1 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | DBP, No change | 99 Participants |
| Danirixin 50 mg | Number of Participants With Worst Case Vital Signs Parameter Results by PCI | SBP, Low | 1 Participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot
Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.
Time frame: Days 1 and 168
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 1, n=17, 19, 24, 26, 19 | 543.0 Hour*nanogram per milliliter |
| Placebo | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 168, n=14, 13, 17, 18, 16 | 752.1 Hour*nanogram per milliliter |
| Danirixin 5 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 1, n=17, 19, 24, 26, 19 | 1373.1 Hour*nanogram per milliliter |
| Danirixin 5 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 168, n=14, 13, 17, 18, 16 | 1701.8 Hour*nanogram per milliliter |
| Danirixin 10 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 168, n=14, 13, 17, 18, 16 | 4170.1 Hour*nanogram per milliliter |
| Danirixin 10 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 1, n=17, 19, 24, 26, 19 | 3851.5 Hour*nanogram per milliliter |
| Danirixin 25 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 168, n=14, 13, 17, 18, 16 | 7682.6 Hour*nanogram per milliliter |
| Danirixin 25 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 1, n=17, 19, 24, 26, 19 | 5485.1 Hour*nanogram per milliliter |
| Danirixin 35 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 168, n=14, 13, 17, 18, 16 | 11538.0 Hour*nanogram per milliliter |
| Danirixin 35 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot | Day 1, n=17, 19, 24, 26, 19 | 8073.4 Hour*nanogram per milliliter |
Secondary
Change From Baseline COPD Assessment Test (CAT) Total Score
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time frame: Baseline, Days 84 and 168
Population: Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -2.02 Scores on a scale | Standard Deviation 0.536 |
| Placebo | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -1.39 Scores on a scale | Standard Deviation 0.557 |
| Danirixin 5 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -0.86 Scores on a scale | Standard Deviation 0.525 |
| Danirixin 5 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -1.39 Scores on a scale | Standard Deviation 0.537 |
| Danirixin 10 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -0.63 Scores on a scale | Standard Deviation 0.524 |
| Danirixin 10 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -1.23 Scores on a scale | Standard Deviation 0.548 |
| Danirixin 25 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -0.55 Scores on a scale | Standard Deviation 0.542 |
| Danirixin 25 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -0.97 Scores on a scale | Standard Deviation 0.56 |
| Danirixin 35 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -1.51 Scores on a scale | Standard Deviation 0.543 |
| Danirixin 35 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -1.56 Scores on a scale | Standard Deviation 0.56 |
| Danirixin 50 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 84, n=89, 97, 92, 89, 88, 85 | -0.36 Scores on a scale | Standard Deviation 0.549 |
| Danirixin 50 mg | Change From Baseline COPD Assessment Test (CAT) Total Score | Day 168, n=84, 94, 86, 87, 85, 83 | -1.32 Scores on a scale | Standard Deviation 0.565 |
Secondary
Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment
Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
Time frame: Baseline, Days 84 and 168
Population: mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.016 Liters | Standard Error 0.0208 |
| Placebo | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.016 Liters | Standard Error 0.0199 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.031 Liters | Standard Error 0.0203 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.043 Liters | Standard Error 0.0191 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.029 Liters | Standard Error 0.0204 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.033 Liters | Standard Error 0.0197 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.018 Liters | Standard Error 0.0206 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.058 Liters | Standard Error 0.0198 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.027 Liters | Standard Error 0.0211 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.012 Liters | Standard Error 0.0201 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.027 Liters | Standard Error 0.021 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.011 Liters | Standard Error 0.0202 |
Secondary
Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment
Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Time frame: Baseline, Days 84 and 168
Population: mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.007 Ratio of FEV1/FVC | Standard Deviation 0.0622 |
| Placebo | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.003 Ratio of FEV1/FVC | Standard Deviation 0.0543 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.001 Ratio of FEV1/FVC | Standard Deviation 0.0554 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.003 Ratio of FEV1/FVC | Standard Deviation 0.0555 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | 0.003 Ratio of FEV1/FVC | Standard Deviation 0.042 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.000 Ratio of FEV1/FVC | Standard Deviation 0.0453 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.013 Ratio of FEV1/FVC | Standard Deviation 0.063 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.015 Ratio of FEV1/FVC | Standard Deviation 0.061 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.000 Ratio of FEV1/FVC | Standard Deviation 0.0402 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | 0.002 Ratio of FEV1/FVC | Standard Deviation 0.0495 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.002 Ratio of FEV1/FVC | Standard Deviation 0.0385 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.014 Ratio of FEV1/FVC | Standard Deviation 0.1636 |
Secondary
Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment
Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
Time frame: Baseline, Days 84 and 168
Population: mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.011 Liters | Standard Error 0.0348 |
| Placebo | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.024 Liters | Standard Error 0.0321 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.079 Liters | Standard Error 0.0335 |
| Danirixin 5 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.054 Liters | Standard Error 0.0313 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.043 Liters | Standard Error 0.0315 |
| Danirixin 10 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.043 Liters | Standard Error 0.0344 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.024 Liters | Standard Error 0.0345 |
| Danirixin 25 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.027 Liters | Standard Error 0.0317 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.036 Liters | Standard Error 0.0351 |
| Danirixin 35 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | -0.049 Liters | Standard Error 0.0326 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 168, n=88, 97, 90, 90, 88, 86 | -0.016 Liters | Standard Error 0.0353 |
| Danirixin 50 mg | Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment | Day 84, n=94, 99, 98, 97, 92, 93 | 0.014 Liters | Standard Error 0.0323 |
Secondary
Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score
The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
Time frame: Baseline, Days 84 and 168
Population: Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -4.11 Scores on a scale | Standard Deviation 1.292 |
| Placebo | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -3.79 Scores on a scale | Standard Deviation 1.172 |
| Danirixin 5 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -3.63 Scores on a scale | Standard Deviation 1.15 |
| Danirixin 5 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -3.44 Scores on a scale | Standard Deviation 1.246 |
| Danirixin 10 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -1.31 Scores on a scale | Standard Deviation 1.146 |
| Danirixin 10 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -4.19 Scores on a scale | Standard Deviation 1.292 |
| Danirixin 25 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -4.94 Scores on a scale | Standard Deviation 1.251 |
| Danirixin 25 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -3.19 Scores on a scale | Standard Deviation 1.148 |
| Danirixin 35 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -2.83 Scores on a scale | Standard Deviation 1.189 |
| Danirixin 35 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -4.12 Scores on a scale | Standard Deviation 1.287 |
| Danirixin 50 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 84, n=93, 97, 94, 96, 91, 90 | -2.48 Scores on a scale | Standard Deviation 1.175 |
| Danirixin 50 mg | Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Day 168, n=85, 96, 86, 90, 86, 85 | -3.41 Scores on a scale | Standard Deviation 1.302 |
Secondary
Change From Baseline Number of Puffs of Rescue Medication Per Day
The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
Time frame: Baseline, Months 1, 2, 3, 4, 5 and 6
Population: Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post Baseline measurement are included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | -0.16 Puffs per day | Standard Error 0.19 |
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | -0.22 Puffs per day | Standard Error 0.187 |
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | -0.18 Puffs per day | Standard Error 0.193 |
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | -0.17 Puffs per day | Standard Error 0.196 |
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | -0.18 Puffs per day | Standard Error 0.184 |
| Placebo | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | 0.00 Puffs per day | Standard Error 0.132 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | 0.36 Puffs per day | Standard Error 0.13 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | 0.21 Puffs per day | Standard Error 0.191 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | 0.17 Puffs per day | Standard Error 0.186 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | 0.27 Puffs per day | Standard Error 0.189 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | 0.42 Puffs per day | Standard Error 0.184 |
| Danirixin 5 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | 0.29 Puffs per day | Standard Error 0.181 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | 0.28 Puffs per day | Standard Error 0.132 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | 0.21 Puffs per day | Standard Error 0.184 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | 0.18 Puffs per day | Standard Error 0.186 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | 0.27 Puffs per day | Standard Error 0.192 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | 0.19 Puffs per day | Standard Error 0.19 |
| Danirixin 10 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | 0.10 Puffs per day | Standard Error 0.195 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | 0.35 Puffs per day | Standard Error 0.185 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | 0.25 Puffs per day | Standard Error 0.182 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | 0.21 Puffs per day | Standard Error 0.19 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | 0.15 Puffs per day | Standard Error 0.13 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | 0.25 Puffs per day | Standard Error 0.187 |
| Danirixin 25 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | 0.15 Puffs per day | Standard Error 0.193 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | 0.07 Puffs per day | Standard Error 0.187 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | -0.06 Puffs per day | Standard Error 0.191 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | -0.04 Puffs per day | Standard Error 0.194 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | 0.07 Puffs per day | Standard Error 0.185 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | -0.03 Puffs per day | Standard Error 0.133 |
| Danirixin 35 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | 0.04 Puffs per day | Standard Error 0.197 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 6, n=86, 95, 88, 91, 85, 86 | 0.28 Puffs per day | Standard Error 0.198 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 1, n=100, 102, 100, 102, 98, 99 | 0.28 Puffs per day | Standard Error 0.133 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 3, n=95, 100, 95, 97, 94, 92 | 0.27 Puffs per day | Standard Error 0.186 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 2, n=96, 100, 98, 97, 98, 96 | 0.33 Puffs per day | Standard Error 0.188 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 5, n=88, 97, 88, 94, 87, 87 | 0.29 Puffs per day | Standard Error 0.192 |
| Danirixin 50 mg | Change From Baseline Number of Puffs of Rescue Medication Per Day | Month 4, n=92, 98, 92, 97, 90, 90 | 0.44 Puffs per day | Standard Error 0.195 |
Secondary
Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots
Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.
Time frame: Days 1 and 168
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 164.9 Nanogram per milliliter |
| Placebo | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 171.9 Nanogram per milliliter |
| Danirixin 5 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 343.1 Nanogram per milliliter |
| Danirixin 5 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 357.3 Nanogram per milliliter |
| Danirixin 10 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1028.8 Nanogram per milliliter |
| Danirixin 10 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 821.2 Nanogram per milliliter |
| Danirixin 25 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1695.0 Nanogram per milliliter |
| Danirixin 25 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1386.2 Nanogram per milliliter |
| Danirixin 35 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 2119.1 Nanogram per milliliter |
| Danirixin 35 mg | Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 2390.5 Nanogram per milliliter |
Secondary
Danirixin Whole Blood Pharmacokinetic Concentration-Time Data
Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.
Time frame: Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168
Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 8 hours, n=15, 19, 24, 26, 19 | 26.1 Nanogram per milliliter | Standard Deviation 13.54 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | 53.2 Nanogram per milliliter | Standard Deviation 73.19 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 10 hours, n=16, 18, 22, 26, 19 | 42.5 Nanogram per milliliter | Standard Deviation 67.85 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 4 hours, n=13, 11, 16, 18, 16 | 90.5 Nanogram per milliliter | Standard Deviation 53.67 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 12 hours, n=16, 16, 21, 26, 18 | 87.2 Nanogram per milliliter | Standard Deviation 174.14 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 12 hours, n=13, 12, 17, 18, 15 | 42.2 Nanogram per milliliter | Standard Deviation 41.29 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 6 hours, n=13, 13, 16, 18, 15 | 55.6 Nanogram per milliliter | Standard Deviation 26.36 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 2 hours, n=14, 13, 17, 18, 16 | 127.4 Nanogram per milliliter | Standard Deviation 88.8 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | 86.7 Nanogram per milliliter | Standard Deviation 85.73 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 10 hours, n=13, 12, 17, 18, 15 | 42.4 Nanogram per milliliter | Standard Deviation 35.98 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 8 hours, n=13, 13, 17, 18, 15 | 41.5 Nanogram per milliliter | Standard Deviation 19.75 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 1 hour, n=16, 18, 24, 26, 19 | 148.3 Nanogram per milliliter | Standard Deviation 104.75 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, Pre-dose, n=97, 99, 102, 102, 100 | 2.1 Nanogram per milliliter | Standard Deviation 19.41 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 1 hours, n=14, 13, 17, 18, 16 | 162.1 Nanogram per milliliter | Standard Deviation 108.88 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 2 hours, n=16, 19, 24, 26, 19 | 115.3 Nanogram per milliliter | Standard Deviation 46 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | 147.7 Nanogram per milliliter | Standard Deviation 91.51 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 4 hours, n=16, 19, 24, 26, 19 | 59.2 Nanogram per milliliter | Standard Deviation 17.79 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | 41.2 Nanogram per milliliter | Standard Deviation 38.02 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 6 hours, n=16, 19, 24, 26, 19 | 34.4 Nanogram per milliliter | Standard Deviation 12.32 |
| Placebo | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | 50.2 Nanogram per milliliter | Standard Deviation 77.78 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 8 hours, n=13, 13, 17, 18, 15 | 102.6 Nanogram per milliliter | Standard Deviation 60.14 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 8 hours, n=15, 19, 24, 26, 19 | 67.8 Nanogram per milliliter | Standard Deviation 61.02 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 4 hours, n=13, 11, 16, 18, 16 | 190.9 Nanogram per milliliter | Standard Deviation 103.35 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | 91.8 Nanogram per milliliter | Standard Deviation 102.43 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 6 hours, n=16, 19, 24, 26, 19 | 100.6 Nanogram per milliliter | Standard Deviation 84.26 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 4 hours, n=16, 19, 24, 26, 19 | 165.3 Nanogram per milliliter | Standard Deviation 136.5 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 10 hours, n=16, 18, 22, 26, 19 | 61.5 Nanogram per milliliter | Standard Deviation 56.67 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 1 hour, n=16, 18, 24, 26, 19 | 343.3 Nanogram per milliliter | Standard Deviation 228.66 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 12 hours, n=16, 16, 21, 26, 18 | 74.7 Nanogram per milliliter | Standard Deviation 82.51 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 10 hours, n=13, 12, 17, 18, 15 | 76.6 Nanogram per milliliter | Standard Deviation 56.95 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 1 hours, n=14, 13, 17, 18, 16 | 314.0 Nanogram per milliliter | Standard Deviation 157.04 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 12 hours, n=13, 12, 17, 18, 15 | 73.1 Nanogram per milliliter | Standard Deviation 41.21 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 6 hours, n=13, 13, 16, 18, 15 | 135.5 Nanogram per milliliter | Standard Deviation 87.39 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 2 hours, n=16, 19, 24, 26, 19 | 277.7 Nanogram per milliliter | Standard Deviation 245.32 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | 99.5 Nanogram per milliliter | Standard Deviation 138 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 2 hours, n=14, 13, 17, 18, 16 | 331.9 Nanogram per milliliter | Standard Deviation 164.1 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, Pre-dose, n=97, 99, 102, 102, 100 | 0.4 Nanogram per milliliter | Standard Deviation 3.92 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | 248.3 Nanogram per milliliter | Standard Deviation 189.3 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | 210.4 Nanogram per milliliter | Standard Deviation 207.54 |
| Danirixin 5 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | 76.2 Nanogram per milliliter | Standard Deviation 106.86 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 1 hour, n=16, 18, 24, 26, 19 | 822.0 Nanogram per milliliter | Standard Deviation 527.47 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 2 hours, n=16, 19, 24, 26, 19 | 707.7 Nanogram per milliliter | Standard Deviation 256.63 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 10 hours, n=13, 12, 17, 18, 15 | 193.9 Nanogram per milliliter | Standard Deviation 128.42 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 12 hours, n=13, 12, 17, 18, 15 | 169.7 Nanogram per milliliter | Standard Deviation 114.2 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, Pre-dose, n=97, 99, 102, 102, 100 | 0.3 Nanogram per milliliter | Standard Deviation 3.06 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | 730.5 Nanogram per milliliter | Standard Deviation 1046.42 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 4 hours, n=16, 19, 24, 26, 19 | 401.5 Nanogram per milliliter | Standard Deviation 188.75 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 6 hours, n=16, 19, 24, 26, 19 | 270.0 Nanogram per milliliter | Standard Deviation 169.37 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 8 hours, n=15, 19, 24, 26, 19 | 213.8 Nanogram per milliliter | Standard Deviation 162.24 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 10 hours, n=16, 18, 22, 26, 19 | 265.0 Nanogram per milliliter | Standard Deviation 396.25 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 12 hours, n=16, 16, 21, 26, 18 | 188.2 Nanogram per milliliter | Standard Deviation 188.27 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | 252.3 Nanogram per milliliter | Standard Deviation 295.15 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 6 hours, n=13, 13, 16, 18, 15 | 289.6 Nanogram per milliliter | Standard Deviation 188.04 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | 212.3 Nanogram per milliliter | Standard Deviation 211.35 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | 217.9 Nanogram per milliliter | Standard Deviation 221.92 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | 530.5 Nanogram per milliliter | Standard Deviation 536.75 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 8 hours, n=13, 13, 17, 18, 15 | 245.1 Nanogram per milliliter | Standard Deviation 165.4 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 1 hours, n=14, 13, 17, 18, 16 | 681.2 Nanogram per milliliter | Standard Deviation 630.86 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 2 hours, n=14, 13, 17, 18, 16 | 574.7 Nanogram per milliliter | Standard Deviation 445.85 |
| Danirixin 10 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 4 hours, n=13, 11, 16, 18, 16 | 452.8 Nanogram per milliliter | Standard Deviation 289.44 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 6 hours, n=16, 19, 24, 26, 19 | 371.5 Nanogram per milliliter | Standard Deviation 335.23 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | 976.1 Nanogram per milliliter | Standard Deviation 839.37 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 10 hours, n=13, 12, 17, 18, 15 | 380.2 Nanogram per milliliter | Standard Deviation 285.81 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 8 hours, n=13, 13, 17, 18, 15 | 444.9 Nanogram per milliliter | Standard Deviation 298.69 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 2 hours, n=16, 19, 24, 26, 19 | 1011.2 Nanogram per milliliter | Standard Deviation 398.82 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 1 hours, n=14, 13, 17, 18, 16 | 1590.3 Nanogram per milliliter | Standard Deviation 1019.32 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 4 hours, n=13, 11, 16, 18, 16 | 805.0 Nanogram per milliliter | Standard Deviation 346.87 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | 1449.5 Nanogram per milliliter | Standard Deviation 949 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, Pre-dose, n=97, 99, 102, 102, 100 | 17.2 Nanogram per milliliter | Standard Deviation 169.33 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 12 hours, n=13, 12, 17, 18, 15 | 481.2 Nanogram per milliliter | Standard Deviation 640.17 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 4 hours, n=16, 19, 24, 26, 19 | 591.5 Nanogram per milliliter | Standard Deviation 302.96 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 10 hours, n=16, 18, 22, 26, 19 | 274.5 Nanogram per milliliter | Standard Deviation 328.04 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 2 hours, n=14, 13, 17, 18, 16 | 1045.2 Nanogram per milliliter | Standard Deviation 414.21 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 12 hours, n=16, 16, 21, 26, 18 | 232.8 Nanogram per milliliter | Standard Deviation 316.67 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | 342.8 Nanogram per milliliter | Standard Deviation 411.28 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 1 hour, n=16, 18, 24, 26, 19 | 1183.5 Nanogram per milliliter | Standard Deviation 760.02 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 8 hours, n=15, 19, 24, 26, 19 | 325.8 Nanogram per milliliter | Standard Deviation 359.79 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 6 hours, n=13, 13, 16, 18, 15 | 554.8 Nanogram per milliliter | Standard Deviation 313.52 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | 372.1 Nanogram per milliliter | Standard Deviation 427.41 |
| Danirixin 25 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | 350.7 Nanogram per milliliter | Standard Deviation 336.07 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 10 hours, n=13, 12, 17, 18, 15 | 715.0 Nanogram per milliliter | Standard Deviation 840.54 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 6 hours, n=16, 19, 24, 26, 19 | 594.9 Nanogram per milliliter | Standard Deviation 525 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | 484.3 Nanogram per milliliter | Standard Deviation 527.47 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 4 hours, n=16, 19, 24, 26, 19 | 904.6 Nanogram per milliliter | Standard Deviation 599.85 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 12 hours, n=13, 12, 17, 18, 15 | 662.4 Nanogram per milliliter | Standard Deviation 877.91 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | 459.5 Nanogram per milliliter | Standard Deviation 421.3 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 2 hours, n=16, 19, 24, 26, 19 | 1472.8 Nanogram per milliliter | Standard Deviation 858.49 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | 1635.6 Nanogram per milliliter | Standard Deviation 1077.48 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 1 hour, n=16, 18, 24, 26, 19 | 1846.2 Nanogram per milliliter | Standard Deviation 979.95 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 6 hours, n=13, 13, 16, 18, 15 | 960.4 Nanogram per milliliter | Standard Deviation 633.37 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | 1331.0 Nanogram per milliliter | Standard Deviation 1220.06 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 4 hours, n=13, 11, 16, 18, 16 | 1459.9 Nanogram per milliliter | Standard Deviation 909.32 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 8 hours, n=13, 13, 17, 18, 15 | 760.8 Nanogram per milliliter | Standard Deviation 679.3 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 1 hours, n=14, 13, 17, 18, 16 | 1725.4 Nanogram per milliliter | Standard Deviation 870.79 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, Pre-dose, n=97, 99, 102, 102, 100 | 3.9 Nanogram per milliliter | Standard Deviation 39.1 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 10 hours, n=16, 18, 22, 26, 19 | 302.3 Nanogram per milliliter | Standard Deviation 255.81 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 12 hours, n=16, 16, 21, 26, 18 | 459.3 Nanogram per milliliter | Standard Deviation 561.53 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 1, 8 hours, n=15, 19, 24, 26, 19 | 428.2 Nanogram per milliliter | Standard Deviation 398.16 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 168, 2 hours, n=14, 13, 17, 18, 16 | 1736.6 Nanogram per milliliter | Standard Deviation 592.51 |
| Danirixin 35 mg | Danirixin Whole Blood Pharmacokinetic Concentration-Time Data | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | 572.0 Nanogram per milliliter | Standard Deviation 738.28 |
Secondary
EXACT Event Duration for All Events
EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.
Time frame: Up to Day 168
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | EXACT Event Duration for All Events | 45.3 Days | Standard Deviation 50.37 |
| Danirixin 5 mg | EXACT Event Duration for All Events | 11.6 Days | Standard Deviation 10.15 |
| Danirixin 10 mg | EXACT Event Duration for All Events | 45.8 Days | Standard Deviation 51.97 |
| Danirixin 25 mg | EXACT Event Duration for All Events | 25.5 Days | Standard Deviation 42.11 |
| Danirixin 35 mg | EXACT Event Duration for All Events | 17.6 Days | Standard Deviation 16.28 |
| Danirixin 50 mg | EXACT Event Duration for All Events | 18.7 Days | Standard Deviation 37.75 |
Secondary
HCRU-defined Exacerbation Duration
The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.
Time frame: Up to Day 196
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HCRU-defined Exacerbation Duration | 10.3 Days | Standard Deviation 7.37 |
| Danirixin 5 mg | HCRU-defined Exacerbation Duration | 12.3 Days | Standard Deviation 8.95 |
| Danirixin 10 mg | HCRU-defined Exacerbation Duration | 12.9 Days | Standard Deviation 9.58 |
| Danirixin 25 mg | HCRU-defined Exacerbation Duration | 14.0 Days | Standard Deviation 8.71 |
| Danirixin 35 mg | HCRU-defined Exacerbation Duration | 10.7 Days | Standard Deviation 7.21 |
| Danirixin 50 mg | HCRU-defined Exacerbation Duration | 14.2 Days | Standard Deviation 9.29 |
Secondary
Number of CAT Responder
A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.
Time frame: Day 84 and Day 168
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 41 Participants |
| Placebo | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 46 Participants |
| Danirixin 5 mg | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 44 Participants |
| Danirixin 5 mg | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 44 Participants |
| Danirixin 10 mg | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 39 Participants |
| Danirixin 10 mg | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 38 Participants |
| Danirixin 25 mg | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 37 Participants |
| Danirixin 25 mg | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 42 Participants |
| Danirixin 35 mg | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 46 Participants |
| Danirixin 35 mg | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 43 Participants |
| Danirixin 50 mg | Number of CAT Responder | Day 84, n=89, 97, 92, 89, 88, 85 | 36 Participants |
| Danirixin 50 mg | Number of CAT Responder | Day 168, n=84, 94, 86, 87, 85, 83 | 44 Participants |
p-value: 0.97390% CI: [0.58, 1.76]Linear mixed model
p-value: 0.82590% CI: [0.53, 1.63]Linear mixed model
p-value: 0.88790% CI: [0.55, 1.66]Linear mixed model
p-value: 0.56790% CI: [0.69, 2.13]Linear mixed model
p-value: 0.50190% CI: [0.72, 2.2]Linear mixed model
Secondary
Number of EXACT Events Per Participant
EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and \>=2= participants in each treatment group who experienced 2 or more events.
Time frame: Up to Day 196
Population: Per Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of EXACT Events Per Participant | 1 | 9 Events |
| Placebo | Number of EXACT Events Per Participant | >=2 | 0 Events |
| Placebo | Number of EXACT Events Per Participant | 0 | 92 Events |
| Danirixin 5 mg | Number of EXACT Events Per Participant | 1 | 6 Events |
| Danirixin 5 mg | Number of EXACT Events Per Participant | 0 | 92 Events |
| Danirixin 5 mg | Number of EXACT Events Per Participant | >=2 | 4 Events |
| Danirixin 10 mg | Number of EXACT Events Per Participant | >=2 | 1 Events |
| Danirixin 10 mg | Number of EXACT Events Per Participant | 1 | 7 Events |
| Danirixin 10 mg | Number of EXACT Events Per Participant | 0 | 92 Events |
| Danirixin 25 mg | Number of EXACT Events Per Participant | 0 | 92 Events |
| Danirixin 25 mg | Number of EXACT Events Per Participant | 1 | 9 Events |
| Danirixin 25 mg | Number of EXACT Events Per Participant | >=2 | 2 Events |
| Danirixin 35 mg | Number of EXACT Events Per Participant | >=2 | 4 Events |
| Danirixin 35 mg | Number of EXACT Events Per Participant | 1 | 10 Events |
| Danirixin 35 mg | Number of EXACT Events Per Participant | 0 | 86 Events |
| Danirixin 50 mg | Number of EXACT Events Per Participant | 0 | 86 Events |
| Danirixin 50 mg | Number of EXACT Events Per Participant | 1 | 10 Events |
| Danirixin 50 mg | Number of EXACT Events Per Participant | >=2 | 3 Events |
Secondary
Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant
Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room \[ER\] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and \>=2= participants in each treatment group who experienced 2 or more events.
Time frame: Up to Day 196
Population: Per Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 7 Exacerbations per participant |
| Placebo | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 66 Exacerbations per participant |
| Placebo | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 28 Exacerbations per participant |
| Danirixin 5 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 17 Exacerbations per participant |
| Danirixin 5 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 34 Exacerbations per participant |
| Danirixin 5 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 51 Exacerbations per participant |
| Danirixin 10 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 61 Exacerbations per participant |
| Danirixin 10 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 23 Exacerbations per participant |
| Danirixin 10 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 16 Exacerbations per participant |
| Danirixin 25 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 12 Exacerbations per participant |
| Danirixin 25 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 28 Exacerbations per participant |
| Danirixin 25 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 63 Exacerbations per participant |
| Danirixin 35 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 30 Exacerbations per participant |
| Danirixin 35 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 15 Exacerbations per participant |
| Danirixin 35 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 55 Exacerbations per participant |
| Danirixin 50 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 0 | 50 Exacerbations per participant |
| Danirixin 50 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | 1 | 36 Exacerbations per participant |
| Danirixin 50 mg | Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant | >=2 | 13 Exacerbations per participant |
Secondary
Number of Responders E-RS in COPD (E-RS): COPD Total Score
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.
Time frame: Month 6
Population: Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 33 Participants |
| Danirixin 5 mg | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 48 Participants |
| Danirixin 10 mg | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 33 Participants |
| Danirixin 25 mg | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 30 Participants |
| Danirixin 35 mg | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 29 Participants |
| Danirixin 50 mg | Number of Responders E-RS in COPD (E-RS): COPD Total Score | 32 Participants |
p-value: 0.80490% CI: [0.54, 1.58]linear mixed model
p-value: 0.08990% CI: [1.02, 2.86]linear mixed model
p-value: 0.88190% CI: [0.62, 1.79]linear mixed model
p-value: 0.67490% CI: [0.51, 1.48]linear mixed model
p-value: 0.98790% CI: [0.59, 1.71]linear mixed model
Secondary
Number of SGRQ Responder
A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.
Time frame: Day 84 and Day 168
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 39 Participants |
| Placebo | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 35 Participants |
| Danirixin 5 mg | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 40 Participants |
| Danirixin 5 mg | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 47 Participants |
| Danirixin 10 mg | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 40 Participants |
| Danirixin 10 mg | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 35 Participants |
| Danirixin 25 mg | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 47 Participants |
| Danirixin 25 mg | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 49 Participants |
| Danirixin 35 mg | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 41 Participants |
| Danirixin 35 mg | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 35 Participants |
| Danirixin 50 mg | Number of SGRQ Responder | Day 84, n=93, 97, 94, 96, 91, 90 | 38 Participants |
| Danirixin 50 mg | Number of SGRQ Responder | Day 168, n=85, 96, 86, 90, 86, 85 | 34 Participants |
p-value: 0.20890% CI: [0.88, 2.59]Linear mixed model
p-value: 0.48290% CI: [0.73, 2.2]Linear mixed model
p-value: 0.23990% CI: [0.86, 2.53]Linear mixed model
p-value: 0.42690% CI: [0.75, 2.26]Linear mixed model
p-value: 0.76390% CI: [0.52, 1.58]Linear mixed model
Secondary
Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire
The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.
Time frame: Days 84 and 168
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | 6.38 Scores on a scale | Standard Deviation 9.511 |
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | -3.69 Scores on a scale | Standard Deviation 14.733 |
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | -0.96 Scores on a scale | Standard Deviation 13.266 |
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | 3.00 Scores on a scale | Standard Deviation 5.964 |
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | 2.25 Scores on a scale | Standard Deviation 5.825 |
| Placebo | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 3.03 Scores on a scale | Standard Deviation 14.409 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 2.20 Scores on a scale | Standard Deviation 11.039 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | -8.50 Scores on a scale | Standard Deviation 7.937 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | -0.43 Scores on a scale | Standard Deviation 8.81 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | 1.64 Scores on a scale | Standard Deviation 8.301 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | -5.75 Scores on a scale | Standard Deviation 6.035 |
| Danirixin 5 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | 1.86 Scores on a scale | Standard Deviation 9.344 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | 2.11 Scores on a scale | Standard Deviation 5.878 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | 2.11 Scores on a scale | Standard Deviation 9.558 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | -3.83 Scores on a scale | Standard Deviation 12.754 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 2.11 Scores on a scale | Standard Deviation 7.553 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | -4.00 Scores on a scale | Standard Deviation 19.204 |
| Danirixin 10 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | -0.17 Scores on a scale | Standard Deviation 7.679 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | 1.25 Scores on a scale | Standard Deviation 3.423 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | 0.42 Scores on a scale | Standard Deviation 2.635 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | 0.00 Scores on a scale | Standard Deviation 6.957 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | 1.25 Scores on a scale | Standard Deviation 9.161 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | 1.89 Scores on a scale | Standard Deviation 11.704 |
| Danirixin 25 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 0.63 Scores on a scale | Standard Deviation 11.413 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | 2.79 Scores on a scale | Standard Deviation 9.278 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 1.52 Scores on a scale | Standard Deviation 9.687 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | 3.67 Scores on a scale | Standard Deviation 11.708 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | 4.08 Scores on a scale | Standard Deviation 6.492 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | -1.20 Scores on a scale | Standard Deviation 8.453 |
| Danirixin 35 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | -4.20 Scores on a scale | Standard Deviation 10.706 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | 0.43 Scores on a scale | Standard Deviation 7.607 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | 4.87 Scores on a scale | Standard Deviation 8.887 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | -4.14 Scores on a scale | Standard Deviation 12.522 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | -0.83 Scores on a scale | Standard Deviation 5.345 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | 4.50 Scores on a scale | Standard Deviation 9.598 |
| Danirixin 50 mg | Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire | Total score, Day 84, n=8, 4, 6, 6, 10, 6 | 2.33 Scores on a scale | Standard Deviation 2.677 |
Secondary
Percent Predicted Normal FEV1
Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.
Time frame: At Screening
Population: Per Protocol Population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Predicted Normal FEV1 | 58.98 Percent predicted FEV1 | Standard Deviation 12.838 |
| Danirixin 5 mg | Percent Predicted Normal FEV1 | 56.75 Percent predicted FEV1 | Standard Deviation 12.038 |
| Danirixin 10 mg | Percent Predicted Normal FEV1 | 56.62 Percent predicted FEV1 | Standard Deviation 11.848 |
| Danirixin 25 mg | Percent Predicted Normal FEV1 | 56.84 Percent predicted FEV1 | Standard Deviation 12.813 |
| Danirixin 35 mg | Percent Predicted Normal FEV1 | 57.51 Percent predicted FEV1 | Standard Deviation 14.076 |
| Danirixin 50 mg | Percent Predicted Normal FEV1 | 57.84 Percent predicted FEV1 | Standard Deviation 12.794 |
Secondary
Severity of EXACT Event
EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.
Time frame: Up to Day 168
Population: Per Protocol Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Severity of EXACT Event | 22.1 Scores on a scale | Standard Deviation 6.6 |
| Danirixin 5 mg | Severity of EXACT Event | 26.7 Scores on a scale | Standard Deviation 3.71 |
| Danirixin 10 mg | Severity of EXACT Event | 22.9 Scores on a scale | Standard Deviation 5.28 |
| Danirixin 25 mg | Severity of EXACT Event | 28.6 Scores on a scale | Standard Deviation 5.68 |
| Danirixin 35 mg | Severity of EXACT Event | 25.0 Scores on a scale | Standard Deviation 5.54 |
| Danirixin 50 mg | Severity of EXACT Event | 26.4 Scores on a scale | Standard Deviation 6.36 |
Secondary
Time to First EXACT Event
The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.
Time frame: Up to Day 168
Population: Per Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Placebo | Time to First EXACT Event | Median time to event | NA Days |
| Danirixin 5 mg | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Danirixin 5 mg | Time to First EXACT Event | Median time to event | NA Days |
| Danirixin 10 mg | Time to First EXACT Event | Median time to event | NA Days |
| Danirixin 10 mg | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Danirixin 25 mg | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Danirixin 25 mg | Time to First EXACT Event | Median time to event | NA Days |
| Danirixin 35 mg | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Danirixin 35 mg | Time to First EXACT Event | Median time to event | NA Days |
| Danirixin 50 mg | Time to First EXACT Event | First quartile (Q1) time to event | NA Days |
| Danirixin 50 mg | Time to First EXACT Event | Median time to event | NA Days |
90% CI: [0.5, 2.6]
90% CI: [0.4, 2.4]
90% CI: [0.6, 3.2]
90% CI: [1, 4.3]
90% CI: [0.9, 4.5]
Secondary
Time to First HCRU-defined COPD Exacerbation
The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
Time frame: Up to Day 196
Population: Per Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 110 Days |
| Placebo | Time to First HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 5 mg | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 47 Days |
| Danirixin 5 mg | Time to First HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 10 mg | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 63 Days |
| Danirixin 10 mg | Time to First HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 25 mg | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 79 Days |
| Danirixin 25 mg | Time to First HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 35 mg | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 70 Days |
| Danirixin 35 mg | Time to First HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 50 mg | Time to First HCRU-defined COPD Exacerbation | Q1 time to event | 57 Days |
| Danirixin 50 mg | Time to First HCRU-defined COPD Exacerbation | Median time to event | 152 Days |
90% CI: [1, 2.2]
90% CI: [0.8, 1.7]
90% CI: [0.7, 1.6]
90% CI: [1, 2.1]
90% CI: [1.1, 2.3]
Secondary
Time to First Severe HCRU-defined COPD Exacerbation
A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
Time frame: Up to Day 196
Population: Per Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Placebo | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 5 mg | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 5 mg | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Danirixin 10 mg | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Danirixin 10 mg | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 25 mg | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Danirixin 25 mg | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 35 mg | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
| Danirixin 35 mg | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Danirixin 50 mg | Time to First Severe HCRU-defined COPD Exacerbation | Q1 time to event | NA Days |
| Danirixin 50 mg | Time to First Severe HCRU-defined COPD Exacerbation | Median time to event | NA Days |
90% CI: [0.7, 5.5]
90% CI: [0.7, 5.8]
90% CI: [0.7, 5.6]
90% CI: [0.9, 6.9]
90% CI: [0.2, 2.7]
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots
Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.
Time frame: Days 1 and 168
Population: Pharmacokinetic Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1.000 Hours |
| Placebo | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1.000 Hours |
| Danirixin 5 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1.000 Hours |
| Danirixin 5 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1.000 Hours |
| Danirixin 10 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1.000 Hours |
| Danirixin 10 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1.000 Hours |
| Danirixin 25 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1.000 Hours |
| Danirixin 25 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1.000 Hours |
| Danirixin 35 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 1, n=17, 19, 24, 26, 19 | 1.000 Hours |
| Danirixin 35 mg | Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots | Day 168, n=14, 13, 17, 18, 16 | 1.542 Hours |