Trial Outcomes & Findings for A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy (NCT NCT04349072)
NCT ID: NCT04349072
Last Updated: 2025-05-23
Results Overview
Participants who decided to proceed with SRT or were eligible for SRT at week 16. Participants with missing assessments were classified as meeting the primary endpoint (did not improve). SRT eligibility using the New York Heart Association Functional Class (NYHA) and left ventricular outflow tract (LVOT) assessments per the 2011 ACCF/AHA guideline clinical and hemodynamic criterion are below: * NYHA Class III or IV/ NYHA Class II with exertion-induced syncope/near syncope, AND * Dynamic LVOT gradient at rest or with provocation \>= 50 mmHg. NYHA Class II at week 16, the following rules will be applied: * NYHA Class II with history of exertional syncope/ syncope at baseline and at W16 is still NYHA Class II, they remain SRT eligible IF their maximal LVOT gradient is ≥ 50mmHg * NYHA Class III/IV at baseline and at W16 has improved to Class II, they are no longer SRT eligible UNLESS they have AE of exertional syncope or pre-syncope during the 16 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
112 participants
Primary outcome timeframe
Week 16
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Mavacamten
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Randomization Period
STARTED
|
56
|
56
|
|
Randomization Period
COMPLETED
|
56
|
55
|
|
Randomization Period
NOT COMPLETED
|
0
|
1
|
|
Double Blind Treatment Period
STARTED
|
56
|
55
|
|
Double Blind Treatment Period
COMPLETED
|
52
|
45
|
|
Double Blind Treatment Period
NOT COMPLETED
|
4
|
10
|
|
Long Term Follow up
STARTED
|
56
|
52
|
|
Long Term Follow up
COMPLETED
|
51
|
42
|
|
Long Term Follow up
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Baseline characteristics by cohort
| Measure |
Mavacamten
n=56 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=56 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 10.55 • n=7 Participants
|
60.3 Years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants
Participants who decided to proceed with SRT or were eligible for SRT at week 16. Participants with missing assessments were classified as meeting the primary endpoint (did not improve). SRT eligibility using the New York Heart Association Functional Class (NYHA) and left ventricular outflow tract (LVOT) assessments per the 2011 ACCF/AHA guideline clinical and hemodynamic criterion are below: * NYHA Class III or IV/ NYHA Class II with exertion-induced syncope/near syncope, AND * Dynamic LVOT gradient at rest or with provocation \>= 50 mmHg. NYHA Class II at week 16, the following rules will be applied: * NYHA Class II with history of exertional syncope/ syncope at baseline and at W16 is still NYHA Class II, they remain SRT eligible IF their maximal LVOT gradient is ≥ 50mmHg * NYHA Class III/IV at baseline and at W16 has improved to Class II, they are no longer SRT eligible UNLESS they have AE of exertional syncope or pre-syncope during the 16 weeks.
Outcome measures
| Measure |
Mavacamten
n=56 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=56 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Composite of Decision to Proceed With Septal Reduction Therapy (SRT) and SRT Guideline Eligible at Week 16
|
10 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: All randomized participants
The NYHA functional classification of heart failure assigns participants to 1 of 4 categories based on the participants symptoms. Baseline values are defined generally as the last available value before the first administration of study drug of analysis interest. Participants with missing NYHA class assessments are treated as no improvement. 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 |
Mavacamten
n=56 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=56 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Number of Participants With at Least One Class Improvement From Baseline in New York Heart Association (NYHA) Class at Week 16
|
35 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: All randomized participants with baseline and week 16 clinical summary scores
The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score.
Outcome measures
| Measure |
Mavacamten
n=55 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=53 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Change From Baseline to Week 16 in Kansas City Cardiomyopathy Questionnaire 23-item Version, Clinical Summary Score (KCCQ-23, CSS)
|
10.4 Score on a scale
Standard Deviation 16.06
|
1.8 Score on a scale
Standard Deviation 12.01
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: All randomized participants with baseline and week 16 serum concentration data
A geometric mean ratio was used to assess the change from baseline to Week 16 in N-Terminal Pro-b-Type Natriuretic Peptide (NT-proBNP). Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise.
Outcome measures
| Measure |
Mavacamten
n=55 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=53 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Change From Baseline to Week 16 in N-Terminal Pro-b-Type Natriuretic Peptide (NT-proBNP)
|
0.35 ng/L
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 83.677
|
1.13 ng/L
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 57.809
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: All randomized participants with baseline and week 16 serum concentration data
A geometric mean ratio was used to assess the change from baseline to week 16 in cardiac troponin. Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise.
Outcome measures
| Measure |
Mavacamten
n=55 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=53 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Change From Baseline to Week 16 in Cardiac Troponin
|
0.50 ng/L
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 100.992
|
1.03 ng/L
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. %CV = 85.716
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: All randomized participants with baseline and week 16 measurements
Change from baseline to week 16 in post-exercise left ventricular outflow tract (LVOT) gradient. Baseline values are defined as the last non-missing value prior to the first dose of study drug unless specified otherwise.
Outcome measures
| Measure |
Mavacamten
n=55 Participants
Participants randomized to the mavacamten group started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 4 and up-titration at Weeks 8 and 12 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
Placebo to Mavacamten
n=53 Participants
One placebo-to-match mavacamten capsule once daily for 16 weeks and then switch to mavacamten. After Week 16 through Week 32, participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration at Week 20 and up-titration at Weeks 24 and 28 (based on the LVEF and VLVOT gradient measured by TTE). Participants could be up- titrated at any scheduled visit after Week 32.
Participants went through 16 weeks of placebo-controlled treatment (Day 1 to Week 16), 16 weeks of active-controlled treatment (Weeks 16 to 32), and 96 weeks of LTE mavacamten (Weeks 32 to 128).
|
|---|---|---|
|
Change From Baseline to Week 16 in Post-Exercise Left Ventricular Outflow Tract (LVOT) Gradient
|
-39.1 mmHg
Standard Deviation 36.51
|
-1.8 mmHg
Standard Deviation 28.82
|
Adverse Events
Mavacamten
Serious events: 21 serious events
Other events: 96 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mavacamten
n=108 participants at risk
Participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration and up-titration (based on the LVEF and VLVOT gradient measured by TTE).
|
Placebo
n=55 participants at risk
One placebo-to-match mavacamten capsule once daily for 16 weeks.
|
|---|---|---|
|
Investigations
Ejection fraction decreased
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Arrhythmia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Atrial fibrillation
|
3.7%
4/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Bradycardia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Cardiac failure acute
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Cardiogenic shock
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Haematochezia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
General disorders
Asthenia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
General disorders
Sudden cardiac death
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
COVID-19
|
1.9%
2/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
Clostridium difficile infection
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
Pneumonia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Dyskinesia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Embolic stroke
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Syncope
|
1.9%
2/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Product Issues
Device inappropriate shock delivery
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Product Issues
Device lead damage
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Psychiatric disorders
Mental status changes
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
2/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Vascular disorders
Hypovolaemic shock
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Vascular disorders
Peripheral venous disease
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Vascular disorders
Shock haemorrhagic
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
Other adverse events
| Measure |
Mavacamten
n=108 participants at risk
Participants started on 5 mg once daily and were titrated to receive 2.5, 5, 10, or 15 mg capsule orally once daily based on possible down-titration and up-titration (based on the LVEF and VLVOT gradient measured by TTE).
|
Placebo
n=55 participants at risk
One placebo-to-match mavacamten capsule once daily for 16 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
12.0%
13/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Palpitations
|
13.0%
14/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.93%
1/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
9.1%
5/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Constipation
|
8.3%
9/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
7/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Gastrointestinal disorders
Nausea
|
8.3%
9/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
General disorders
Chest discomfort
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
General disorders
Chest pain
|
6.5%
7/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
General disorders
Fatigue
|
16.7%
18/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
Bronchitis
|
6.5%
7/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
COVID-19
|
36.1%
39/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
15/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Infections and infestations
Urinary tract infection
|
13.9%
15/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Investigations
Ejection fraction decreased
|
11.1%
12/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Investigations
SARS-CoV-2 test positive
|
8.3%
9/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Metabolism and nutrition disorders
Gout
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
13/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
1.8%
1/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Dizziness
|
14.8%
16/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
5.5%
3/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Headache
|
10.2%
11/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
9.1%
5/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Nervous system disorders
Syncope
|
5.6%
6/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Psychiatric disorders
Anxiety
|
7.4%
8/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
7/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
11/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
5.5%
3/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
9.3%
10/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
7/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
0.00%
0/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
|
Vascular disorders
Hypertension
|
9.3%
10/108 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
3.6%
2/55 • Other (Not including Serious) Adverse Events (AEs) and Serious Adverse Events (SAEs) are collected from first dose to 56 days post last dose (Up to approximately 146 weeks). Participants were assessed for All-cause mortality from their date of randomization to study completion (Up to approximately 46 months.)
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. 108 participants in total received mavacamtem (56 participants who started treatment with mavacamten plus the 52 participants who originally received placebo and switched over at week 16).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
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