Endometriosis
Conditions
Brief summary
The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Interventions
DRUGBAY1817080
Tablet, oral administration
DRUGElagolix
Tablet, oral administration
DRUGPlacebo
Tablet, oral administration
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind to placebo and open-label for active comparator
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be ≥ 18 years of age at the time of signing the informed consent * Visually-confirmed endometriosis: detection of endometriotic lesions during laparoscopy or laparotomy (with or without pathological diagnosis) within 10 years but no less than 8 weeks from Visit 1a (surgically diagnosed endometriosis). For Japan only and limited to no more than half of all randomized Japanese participants: the diagnosis can be based on previous imaging (i.e. endometriosis lesion detected by ultrasound or MRI). If the participant was diagnosed by ultrasound, the lesion must be visualized again by ultrasound at the screening visit. If the participant was diagnosed by MRI, the diagnosis must have been made within 12 months before Visit 1a (clinically diagnosed endometriosis). * Both sub-criteria regarding pain symptoms must be fulfilled: * At Visit 1a, participant presents self-reported moderate to severe pain which - based on the judgement of the investigator - carries a reasonable likelihood to translate into a severity of pain symptoms sufficient to fulfil the eligibility criterion and be caused by endometriosis, and * During the screening period at least 24 daily ESD entries during the 28 consecutive days starting on the first day with menstrual bleeding at or after Visit 1a and entries in the ESD item 1a ('worst pain' on the daily numerical rating scale) sum up to 98 or more. * Willingness to use standardized rescue pain medications for EAPP (i.e. ibuprofen, acetaminophen and tramadol) and not use any prophylactic pain medication, according to investigator's instruction * Ability to swallow the study intervention, i.e., the different kinds of tablets, as complete units * Good general health (except for findings related to endometriosis) as proven by medical history, physical and gynecological examinations and laboratory test results * Normal or clinically insignificant cervical cytology not requiring further follow-up: * A cervical cytology sample has to be obtained during screening, or * A documented normal result has to be available from cervical cytology conducted within 12 months prior to Visit 1a. * Human papilloma virus (HPV) testing in participants with atypical squamous cells of unknown significance (ASCUS) will be used as an adjunctive test automatically. Participants with ASCUS can be included if they are negative for high-risk HPV strains.
Exclusion criteria
* Current pregnancy or less than 3 months since delivery, abortion or stop of lactation before Visit 1a * Hypersensitivity to any ingredient of the study intervention and/or the standardized rescue medications * Known osteoporosis * History of a low trauma fracture * Contraindications for elagolix or the standardized rescue medications * Current malignancy or history of cancer (exception: basal cell or squamous cell carcinoma of the skin) within the last 5 years prior to Visit 1a * Any other diseases or conditions that according to the investigator can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study intervention (e.g. extremely low body weight, chronic bowel disease, Crohn's disease and ulcerative colitis) * Menopause or signs of menopausal transition, such as absence of regular menstrual cycles based on investigator's judgment (absence of information regarding menstrual bleeding pattern e.g. due to long term use of hormonal contraception is not an exclusion criterion) * Any disease or condition that may worsen during the study period according to the assessment and opinion of the investigator * Abnormal uterine bleeding in terms of regularity or heaviness (with the exception of heavy menstrual bleeding that does not require treatment) * Any findings that require further diagnostic procedures to avoid harm to the participant (e.g. ovarian tumors of uncertain origin or pelvic masses of unclear etiology) * Any serious or unstable diseases or medical conditions, including psychiatric disorders, that might interfere with the conduct of the study or the interpretation of the result, including for example: * history of hysterectomy and/or bilateral oophorectomy * any conditions considered to contribute significantly to pelvic pain by the investigator, e.g. fibromyalgia, uterine fibroids, irritable bowel syndrome or other bowel disorders * any other underlying diseases requiring regular use of pain medication (e.g. migraine) * history of or current anxiety or depression unless stable with or without medical treatment ≥ 6 months before Visit 1a * Major surgery scheduled during the study period * Non-responsiveness of EAPP to earlier treatment with GnRH-agonists or GnRH-antagonists, based on the judgement of the investigator * SARS-CoV-2- positive virus RNA test within 4 weeks prior to Visit 1a reported by participant, regardless of whether the participant had symptoms * History of COVID-19 infection with persistent/ongoing symptoms * Contact with SARS-CoV-2- positive or COVID-19 patient within the last 4 weeks prior to Visit 1a * Intake of medication prohibited due to potential drug-drug interaction * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results, including: * hormonal medications * other treatments intended for endometriosis/pelvic pain during participation in the study, including the use of herbal products or traditional Chinese medicine for symptom relief, with the exception of the standardized rescue pain medications * Simultaneous participation in another clinical trial with investigational medicinal product(s). Participation in another trial 3 months prior to Visit 1a that might have an impact on the study objectives, at the discretion of the investigator * Previous assignment to study intervention (randomization) in this study (allowing previously randomized participants to be re-included into the study may lead to bias) * Laboratory values outside the inclusion range (specified in the laboratory manual) and considered clinically relevant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | change from baseline to week 12 | The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | change from baseline to week 12 | The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average. |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | up to 14 days after the last study medication intake | A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake. |
Countries
Austria, Belgium, Bulgaria, Canada, China, Czechia, Estonia, Finland, Germany, Greece, Hungary, Italy, Japan, Latvia, Lithuania, Norway, Poland, Slovakia, Spain, United States
Participant flow
Recruitment details
This multinational study was conducted between 29 JAN 2021 First Patient First Visit (FPFV) and 03 MAY 2022 Last Patient Last Visit (LPLV) in 20 countries/regions: Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Estonia, Finland , Germany, Greece, Hungary, Italy, Japan, Lithuania, Latvia, Norway, Poland, Slovakia, Spain, United States
Pre-assignment details
A total of 215 participants were randomized to 5 treatment arms (44 to eliapixant, 44 to eliapixant, 43 to eliapixant, 43 to placebo, and 41 to Elagolix).
Participants by arm
| Arm | Count |
|---|---|
| Eliapixant (BAY1817080) 25 mg 25mg eliapixant twice daily for 12 weeks | 44 |
| Eliapixant (BAY1817080) 75 mg 75mg eliapixant twice daily for 12 weeks | 44 |
| Eliapixant (BAY1817080) 150 mg 150mg eliapixant twice daily for 12 weeks | 43 |
| Placebo Placebo for eliapixant twice daily for 12 weeks | 43 |
| Elagolix 150mg 150mg Elagolix once daily for 12 weeks | 41 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 3 |
| Overall Study | Other reason | 0 | 1 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 10 | 15 | 12 | 13 | 9 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 4 | 3 | 4 |
Baseline characteristics
| Characteristic | Eliapixant (BAY1817080) 25 mg | Eliapixant (BAY1817080) 75 mg | Eliapixant (BAY1817080) 150 mg | Placebo | Elagolix 150mg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 44 Participants | 43 Participants | 43 Participants | 41 Participants | 215 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 12 Participants | 11 Participants | 12 Participants | 0 Participants | 48 Participants |
| Race/Ethnicity, Customized Black or african american | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 31 Participants | 30 Participants | 29 Participants | 39 Participants | 160 Participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 43 Participants | 43 Participants | 41 Participants | 215 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 | 0 / 38 | 0 / 37 | 0 / 38 |
| other Total, other adverse events | 23 / 39 | 20 / 38 | 29 / 38 | 27 / 37 | 28 / 38 |
| serious Total, serious adverse events | 0 / 39 | 2 / 38 | 2 / 38 | 1 / 37 | 1 / 38 |
Outcome results
Primary
Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS)
The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average.
Time frame: change from baseline to week 12
Population: The Elagolix arm was not included in the primary per protocol set (pPPS) simply because it's not part of the primary objective which was to assess the dose-response relationship and demonstrate efficacy of BAY 1817080 compared to placebo in women with symptomatic endometriosis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eliapixant (BAY1817080) 25 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Baseline | 6.40 units on a scale | Standard Deviation 1.66 |
| Eliapixant (BAY1817080) 25 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12: Change from Baseline | -1.56 units on a scale | Standard Deviation 1.35 |
| Eliapixant (BAY1817080) 25 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12 | 4.57 units on a scale | Standard Deviation 2.1 |
| Eliapixant (BAY1817080) 75 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Baseline | 6.13 units on a scale | Standard Deviation 1.77 |
| Eliapixant (BAY1817080) 75 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12: Change from Baseline | -2.12 units on a scale | Standard Deviation 2.66 |
| Eliapixant (BAY1817080) 75 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12 | 4.15 units on a scale | Standard Deviation 2.49 |
| Eliapixant (BAY1817080) 150 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12 | 5.15 units on a scale | Standard Deviation 2.42 |
| Eliapixant (BAY1817080) 150 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Baseline | 6.95 units on a scale | Standard Deviation 1.38 |
| Eliapixant (BAY1817080) 150 mg | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12: Change from Baseline | -1.88 units on a scale | Standard Deviation 2.03 |
| Placebo | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Baseline | 6.14 units on a scale | Standard Deviation 1.96 |
| Placebo | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12: Change from Baseline | -1.89 units on a scale | Standard Deviation 1.91 |
| Placebo | Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) | Week 12 | 4.29 units on a scale | Standard Deviation 1.71 |
Comparison: 80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 1280% CI: [-2.13, -1.14]Mixed Models Analysis
Comparison: 80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 1280% CI: [-2.66, -1.61]Mixed Models Analysis
Comparison: 80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 1280% CI: [-2.48, -1.43]Mixed Models Analysis
Comparison: 80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 1280% CI: [-2.44, -1.45]Mixed Models Analysis
Secondary
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set
The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average.
Time frame: change from baseline to week 12
Population: Per protocol set (PPS): includes 183 participants, which is 85.1% of the FAS population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Eliapixant (BAY1817080) 25 mg | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | -1.60 units on a scale | Standard Error 0.4 |
| Eliapixant (BAY1817080) 75 mg | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | -2.07 units on a scale | Standard Error 0.42 |
| Eliapixant (BAY1817080) 150 mg | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | -1.97 units on a scale | Standard Error 0.42 |
| Placebo | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | -1.89 units on a scale | Standard Error 0.4 |
| Elagolix 150 mg | Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set | -2.69 units on a scale | Standard Error 0.41 |
Comparison: Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS95% CI: [-0.77, 1.35]
Comparison: Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS95% CI: [-1.27, 0.91]
Comparison: Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS98% CI: [-1.17, 1.02]
Comparison: Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS80% CI: [-0.4, 0.98]
Comparison: Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS80% CI: [-0.89, 0.53]
Comparison: Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS80% CI: [-0.79, 0.64]
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAE)
A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Time frame: up to 14 days after the last study medication intake
Population: Safety analysis set (SAF) includes 190 participants (88.4%) since 25 participants (11.6%) did not receive any study intervention and was excluded from SAF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE | 23 Participants |
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related TEAE | 4 Participants |
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any serious TEAE | 0 Participants |
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related serious TEAE | 0 Participants |
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE with outcome death | 0 Participants |
| Eliapixant (BAY1817080) 25 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE resulting in permanent discontinuation of studly drug | 0 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE with outcome death | 0 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE resulting in permanent discontinuation of studly drug | 1 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE | 21 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any serious TEAE | 2 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related serious TEAE | 0 Participants |
| Eliapixant (BAY1817080) 75 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related TEAE | 6 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related serious TEAE | 1 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE with outcome death | 0 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE | 29 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any serious TEAE | 2 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related TEAE | 10 Participants |
| Eliapixant (BAY1817080) 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE resulting in permanent discontinuation of studly drug | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related serious TEAE | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related TEAE | 10 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any serious TEAE | 1 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE resulting in permanent discontinuation of studly drug | 2 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE with outcome death | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE | 27 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE with outcome death | 0 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any serious TEAE | 1 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related TEAE | 13 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE resulting in permanent discontinuation of studly drug | 1 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any drug related serious TEAE | 1 Participants |
| Elagolix 150 mg | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Any TEAE | 28 Participants |