Trial Outcomes & Findings for Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER (NCT NCT03496168)

NCT ID: NCT03496168

Last Updated: 2025-01-09

Results Overview

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: * Results in death * Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions * Results in a congenital abnormality or birth defect * Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks)
• Results posted on: 2025-01-09

Participant Flow

13 Participants enrolled and treated

Participant milestones

Measure	Mavacamtem Mavacamtem
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Mavacamtem Mavacamtem
Overall Study Other Reasons	1
Overall Study Adverse Event	1

Baseline Characteristics

Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

Baseline characteristics by cohort

Measure	Mavacamtem n=13 Participants Mavacamtem
Age, Continuous	57.8 Years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks)

Population: All Treated Participants

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

An SAE is defined as any untoward medical occurrence at any dose that:

• Results in death
• Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred)
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions
• Results in a congenital abnormality or birth defect
• Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events TESAEs	5 Participants
Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events TEAEs	13 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who had died due to cardiovascular reasons.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Had Cardiovascular Death	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who experienced sudden death

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Experienced Sudden Death	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who were hospitalized for cardiovascular reasons.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Were Hospitalized for Cardiovascular Reasons.	1 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants with heart failure due to systolic dysfunction, defined as asymptomatic LVEF < 50%

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants With Heart Failure Due to Systolic Dysfunction, Defined as Asymptomatic LVEF < 50%	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants with LVEF < 50% as measured by echocardiography.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants With LVEF < 50% as Measured by Echocardiography.	2 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who experienced myocardial infarction.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Were Experienced Myocardial Infarction	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All treated participants

Types of Ventricular Arrhythmias measured in this endpoint will be:

Ventricular Tachycardia Ventricular Fibrilation Ventricular Flutter

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants With Ventricular Arrhythmias. Ventricular Tachycardia	1 Participants
Number of Participants With Ventricular Arrhythmias. Ventricular Fibrilation	0 Participants
Number of Participants With Ventricular Arrhythmias. Ventricular Flutter	0 Participants
Number of Participants With Ventricular Arrhythmias. Torsades De Pointe	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All treated participants

Number of participants who experienced syncope.

Syncope will be defined as participants who experienced dizziness or orthostatic hypotension.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Experienced Syncope Dizziness	2 Participants
Number of Participants Who Experienced Syncope Orthostatic Hypotension	1 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who were experienced seizures.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Experienced Seizures	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All Treated Participants

Number of participants who were experienced strokes.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Were Experienced Strokes	0 Participants

PRIMARY outcome

Timeframe: From first dose to end of study, (approximately 260 weeks)

Population: All treated participants

Number of participants with a change in QTcF intervals.

QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR/1000)

RR = Respiration rate

QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants With a Change in QT and QTcF Intervals. Post Baseline QTcF > 480msec	1 Participants
Number of Participants With a Change in QT and QTcF Intervals. Post Baseline QTcF > 450msec	7 Participants
Number of Participants With a Change in QT and QTcF Intervals. Post Baseline QTcF > 500msec	1 Participants
Number of Participants With a Change in QT and QTcF Intervals. Change from Baseline QTcF > 30 msec	2 Participants
Number of Participants With a Change in QT and QTcF Intervals. Change from Baseline QTcF > 60 msec	1 Participants

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252

Population: Safety Analysis Population

Number of participants with changes of Post-exercise left ventricular outflow tract (LVOT) gradient over time

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 30 mmHg to < 50 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 50 mmHg	2 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · < 30 mmHg	9 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 30 mmHg to < 50 mmHg	1 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 30 mmHg to < 50 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 50 mmHg	2 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · < 30 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 30 mmHg to < 50 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 50 mmHg	13 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · < 30 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 30 mmHg to < 50 mmHg	3 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 50 mmHg	10 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · < 30 mmHg	6 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 30 mmHg to < 50 mmHg	3 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 50 mmHg	2 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · < 30 mmHg	8 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 30 mmHg to < 50 mmHg	0 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 50 mmHg	3 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · < 30 mmHg	10 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 50 mmHg	2 Participants
Post-exercise Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · < 30 mmHg	9 Participants

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252

Population: Safety Analysis Population

Resting left ventricular outflow tract (LVOT) gradient over time

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · < 30 mmHg	3 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 30 mmHg to < 50 mmHg	2 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 30 mmHg to < 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 50 mmHg	5 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · < 30 mmHg	11 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 30 mmHg to < 50 mmHg	1 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · < 30 mmHg	11 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 30 mmHg to < 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · < 30 mmHg	11 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 50 mmHg	8 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · < 30 mmHg	8 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 30 mmHg to < 50 mmHg	1 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · < 30 mmHg	10 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 30 mmHg to < 50 mmHg	1 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 50 mmHg	1 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · < 30 mmHg	11 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 30 mmHg to < 50 mmHg	0 Participants
Resting Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 50 mmHg	0 Participants

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 48, Week 72, Week 156, Week 204 and Week 252

Population: Safety Analysis Population

Post Valsalva left ventricular outflow tract (LVOT) gradient over time

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 30 mmHg to < 50 mmHg	0 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · >= 50 mmHg	3 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · < 30 mmHg	10 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 30 mmHg to < 50 mmHg	0 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 252 · >= 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · < 30 mmHg	0 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 30 mmHg to < 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Baseline · >= 50 mmHg	11 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · < 30 mmHg	3 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 30 mmHg to < 50 mmHg	2 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 4 · >= 50 mmHg	8 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · < 30 mmHg	9 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 30 mmHg to < 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 48 · >= 50 mmHg	2 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · < 30 mmHg	9 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 30 mmHg to < 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 72 · >= 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · < 30 mmHg	10 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 30 mmHg to < 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 156 · >= 50 mmHg	1 Participants
Post Valsalva Left Ventricular Outflow Tract (LVOT) Gradient Over Time Week 204 · < 30 mmHg	9 Participants

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252

Population: Safety Analysis Population

Participants with >= 1 NYHA function class improvement.

The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms.

Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 4	15.4 Percentage of Participants Interval 1.92 to 45.45
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 8	46.2 Percentage of Participants Interval 19.22 to 74.87
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 24	76.9 Percentage of Participants Interval 46.19 to 94.96
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 48	75.0 Percentage of Participants Interval 42.81 to 94.51
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 72	90.9 Percentage of Participants Interval 58.72 to 99.77
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 96	83.3 Percentage of Participants Interval 51.59 to 97.91
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 120	91.7 Percentage of Participants Interval 61.52 to 99.79
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 144	91.7 Percentage of Participants Interval 61.52 to 99.79
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 156	91.7 Percentage of Participants Interval 61.52 to 99.79
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 180	83.3 Percentage of Participants Interval 51.59 to 97.91
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 204	83.3 Percentage of Participants Interval 51.59 to 97.91
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 228	83.3 Percentage of Participants Interval 51.59 to 97.91
Participants With >= 1 NYHA Function Class Improvement Change from baseline at week 252	90.9 Percentage of Participants Interval 58.72 to 99.77

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252

Population: Safety Analysis Population

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered 23-item questionnaire questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Overall KCCQ Pro score is the average of all the domains, symptom frequency and symptom burden scores, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 252	89.489 Scores on a Scale Standard Deviation 12.7977
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 4	5.809 Scores on a Scale Standard Deviation 8.7200
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 8	12.304 Scores on a Scale Standard Deviation 15.7392
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 24	16.931 Scores on a Scale Standard Deviation 18.4502
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 48	16.345 Scores on a Scale Standard Deviation 18.2986
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 72	18.600 Scores on a Scale Standard Deviation 16.7875
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 96	16.162 Scores on a Scale Standard Deviation 18.2376
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 120	18.142 Scores on a Scale Standard Deviation 15.9249
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 144	17.860 Scores on a Scale Standard Deviation 15.5829
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 156	18.750 Scores on a Scale Standard Deviation 15.5701
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 180	16.674 Scores on a Scale Standard Deviation 15.6328
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 204	19.661 Scores on a Scale Standard Deviation 15.9783
Mean Change From Baseline in the Overall KCCQ PRO Score. Change from baseline at week 228	91.122 Scores on a Scale Standard Deviation 10.6882

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252

Population: Safety Analysis Population

Mean change from baseline in Serum N-terminal pro B-type natriuretic peptide levels.

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 4	-1017.4 ng/L Standard Deviation 1540.78
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 8	-1440.6 ng/L Standard Deviation 2063.89
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 24	-1512.8 ng/L Standard Deviation 2242.40
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 48	-1579.2 ng/L Standard Deviation 2328.81
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 72	-1708.4 ng/L Standard Deviation 2448.93
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 96	-1579.1 ng/L Standard Deviation 2339.95
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 120	-1692.7 ng/L Standard Deviation 2426.02
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 144	-1507.8 ng/L Standard Deviation 2407.34
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 156	-1673.5 ng/L Standard Deviation 2460.82
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 180	-1433.6 ng/L Standard Deviation 2347.72
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 204	-1568.7 ng/L Standard Deviation 2400.63
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 228	-1325.5 ng/L Standard Deviation 2368.77
Mean Change From Baseline in Serum NT-proBNP. Change from baseline at week 252	-1681.5 ng/L Standard Deviation 2409.67

PRIMARY outcome

Timeframe: 252 weeks

Population: All Treated Participants

Number of participants who received septal reduction therapy

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Number of Participants Who Received Septal Reduction Therapy	0 Participants

PRIMARY outcome

Timeframe: At Baseline, Week 4, Week 8, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 156, Week 180, Week 204, Week 228 and Week 252

Population: PK Analysis Population

Plasma concentration of Mavacamen overtime

Outcome measures

Measure	Mavacamtem n=13 Participants Mavacamtem
Plasma Concentration of Mavacamen Overtime Week 252	334.57 ng/mL Geometric Coefficient of Variation 52.1
Plasma Concentration of Mavacamen Overtime Week 4	166.51 ng/mL Geometric Coefficient of Variation 32.1
Plasma Concentration of Mavacamen Overtime Week 8	334.65 ng/mL Geometric Coefficient of Variation 21.5
Plasma Concentration of Mavacamen Overtime Week 24	396.18 ng/mL Geometric Coefficient of Variation 31.7
Plasma Concentration of Mavacamen Overtime Week 48	400.15 ng/mL Geometric Coefficient of Variation 35.1
Plasma Concentration of Mavacamen Overtime Week 72	407.27 ng/mL Geometric Coefficient of Variation 24.4
Plasma Concentration of Mavacamen Overtime Week 96	422.82 ng/mL Geometric Coefficient of Variation 29.3
Plasma Concentration of Mavacamen Overtime Week 120	399.17 ng/mL Geometric Coefficient of Variation 33.2
Plasma Concentration of Mavacamen Overtime Week 144	410.23 ng/mL Geometric Coefficient of Variation 42.8
Plasma Concentration of Mavacamen Overtime Week 156	400.02 ng/mL Geometric Coefficient of Variation 44.1
Plasma Concentration of Mavacamen Overtime Week 180	265.04 ng/mL Geometric Coefficient of Variation 57.9
Plasma Concentration of Mavacamen Overtime Week 204	376.25 ng/mL Geometric Coefficient of Variation 69.5
Plasma Concentration of Mavacamen Overtime Week 228	355.29 ng/mL Geometric Coefficient of Variation 72.3

Adverse Events

Mavacamten

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mavacamten n=13 participants at risk Mavacamtem
Cardiac disorders Mitral valve incompetence	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholecystitis acute	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Lumbar vertebral fracture	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Spinal compression fracture	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Subdural haematoma	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Lumbar radiculopathy	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Aortic stenosis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Measure	Mavacamten n=13 participants at risk Mavacamtem
Vascular disorders Aortic stenosis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Essential hypertension	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	30.8% 4/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Leukocytosis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac flutter	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Mitral valve incompetence	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Palpitations	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Supraventricular tachycardia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Ventricular tachycardia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Tinnitus	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Thyroid mass	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Eyelid ptosis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal discomfort	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal hernia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dental caries	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Umbilical hernia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	38.5% 5/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Peripheral swelling	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Biliary obstruction	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Acute sinusitis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bronchitis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Fungal skin infection	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Influenza	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Laryngitis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	38.5% 5/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Prostate infection	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	38.5% 5/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Ligament sprain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Post procedural constipation	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Post procedural hypotension	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Procedural pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Urinary retention postoperative	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Cardiac murmur	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Cortisol decreased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Drug level increased	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Ejection fraction decreased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Electrocardiogram QT prolonged	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Glycosylated haemoglobin increased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations SARS-CoV-2 test positive	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Troponin increased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Vitamin D decreased	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Insulin resistance	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Vitamin D deficiency	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	38.5% 5/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Flank pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Synovial cyst	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Tendon pain	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cluster headache	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness exertional	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness postural	23.1% 3/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Facial spasm	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Lethargy	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Migraine	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neuropathy peripheral	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ophthalmic migraine	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Paraesthesia	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Sciatica	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Depression	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Haematuria	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Nephrolithiasis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Pollakiuria	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Ureterolithiasis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Urinary incontinence	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Prostatitis	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.1% 3/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dermatitis contact	15.4% 2/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Eczema	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Eczema nummular	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pain of skin	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Orthostatic hypotension	7.7% 1/13 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 56 days): Approximately 240 Weeks All-Cause mortality (From randomization to end of study): Approximately 260 Weeks The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 1-855-907-3286

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER