Trial Outcomes & Findings for Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM (NCT NCT05767346)
NCT ID: NCT05767346
Last Updated: 2026-06-09
Results Overview
Effect of aficamten compared with metoprolol succinate on exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Exercise capacity was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Aficamten
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
87
|
|
Overall Study
Completed Treatment
|
87
|
84
|
|
Overall Study
COMPLETED
|
87
|
86
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Aficamten
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
Baseline characteristics by cohort
| Measure |
Aficamten
n=88 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=87 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Age, Continuous
|
58.9 Years
STANDARD_DEVIATION 13.33 • n=20 Participants
|
56.5 Years
STANDARD_DEVIATION 13.06 • n=20 Participants
|
57.7 Years
STANDARD_DEVIATION 13.21 • n=40 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=20 Participants
|
50 Participants
n=20 Participants
|
102 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=20 Participants
|
73 Participants
n=20 Participants
|
146 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
70 Participants
n=20 Participants
|
70 Participants
n=20 Participants
|
140 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
13 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Region of Enrollment
Brazil
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Region of Enrollment
China
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Region of Enrollment
Denmark
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
|
19.52 mL/kg/min
STANDARD_DEVIATION 4.786 • n=20 Participants
|
20.19 mL/kg/min
STANDARD_DEVIATION 5.313 • n=20 Participants
|
19.86 mL/kg/min
STANDARD_DEVIATION 5.052 • n=40 Participants
|
|
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
|
65.5 Points on a Scale
STANDARD_DEVIATION 17.01 • n=20 Participants
|
66.0 Points on a Scale
STANDARD_DEVIATION 5.99 • n=20 Participants
|
65.8 Points on a Scale
STANDARD_DEVIATION 16.47 • n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 pVO2 assessment data
Effect of aficamten compared with metoprolol succinate on exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Exercise capacity was determined through changes in peak oxygen uptake (pVO2) after 24 weeks of treatment. pVO2 was measured by cardiopulmonary exercise testing (CPET) on a treadmill or bicycle. A higher pVO2 indicates better cardiorespiratory fitness.
Outcome measures
| Measure |
Aficamten
n=83 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=82 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
|
1.07 mL/kg/min
Standard Deviation 2.767
|
-1.24 mL/kg/min
Standard Deviation 2.186
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants
Effect of aficamten compared with metoprolol succinate on NYHA Functional Classification
Outcome measures
| Measure |
Aficamten
n=88 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=87 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Proportion of Patients With ≥1 Class Improvement in New York Heart Association (NYHA) Functional Class
|
45 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 KCCQ-CSS assessment data
Effect of aficamten compared with metoprolol succinate on participant health status was measured by change in KCCQ-CSS. The KCCQ is a patient-reported outcome designed to assess the physical limitations, symptoms, self-efficacy, quality of life, and social limitation of patients with heart failure symptoms. The CSS is the sum of the physical limitation score and the total symptom score. The KCCQ-Clinical Symptoms Score (KCCQ-CSS) is scored on a scale from 0 to 100, with higher scores indicating better physical functioning and symptoms.
Outcome measures
| Measure |
Aficamten
n=87 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=86 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
|
15.3 points on a scale
Standard Error 1.56
|
8.3 points on a scale
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 LVMI assessment data
Effect of aficamten on mass of the heart as compared with metoprolol succinate
Outcome measures
| Measure |
Aficamten
n=79 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=80 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change in Left Ventricular Mass Index (LVMI)
|
-9.19 g/m^2
Standard Error 2.492
|
-4.34 g/m^2
Standard Error 2.486
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 LAVI assessment data
Effect of aficamten on size of the heart as compared with metoprolol succinate
Outcome measures
| Measure |
Aficamten
n=87 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=86 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change in Left Atrial Volume Index (LAVI)
|
-3.87 mL/m^2
Standard Error 0.785
|
3.12 mL/m^2
Standard Error 0.789
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 NT-proBNP assessment data
Effect of aficamten on NT-proBNP as compared with metoprolol succinate. For change in NT-proBNP from baseline to Week 24, the log transformed proportional change up to Week 24 was analyzed using a mixed model for repeated measures (MMRM) then the estimate was back transformed to obtain the ratio.
Outcome measures
| Measure |
Aficamten
n=87 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=86 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change From Baseline Values in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
|
0.26 ratio
Interval 0.23 to 0.31
|
1.38 ratio
Interval 1.18 to 1.61
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set: all randomized participants with available Week 24 LVOT-G assessment data
Effect of aficamten on post-Valsalva LVOT-G as compared with metoprolol succinate
Outcome measures
| Measure |
Aficamten
n=83 Participants
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=85 Participants
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Change in Post-Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
|
-40.34 mmHg
Standard Error 3.098
|
-5.44 mmHg
Standard Error 3.100
|
Adverse Events
Aficamten
Serious events: 7 serious events
Other events: 46 other events
Deaths: 1 deaths
Metoprolol
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aficamten
n=88 participants at risk
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=87 participants at risk
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
2/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal wall hematoma
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
General disorders
Sudden death
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Nervous system disorders
Paresthesia
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Hematoma
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Shock hemorrhagic
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
Other adverse events
| Measure |
Aficamten
n=88 participants at risk
Participants received doses of 5 mg, 10 mg, 15 mg or 20 mg of aficamten
|
Metoprolol
n=87 participants at risk
Participants received 50 mg, 100 mg, 150 mg or 200 mg of metoprolol succinate plus placebo for aficamten
|
|---|---|---|
|
General disorders
Fatigue
|
5.7%
5/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
10.3%
9/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.6%
12/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
11.5%
10/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
10.2%
9/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
2.3%
2/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
9.1%
8/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
4.6%
4/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
8.0%
7/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
4.6%
4/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
7/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
6.9%
6/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.8%
6/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
17.2%
15/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
6.8%
6/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
6.9%
6/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.7%
5/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
0.00%
0/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Infections and infestations
Influenza
|
5.7%
5/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
1.1%
1/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Cardiac disorders
Palpitations
|
3.4%
3/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
9.2%
8/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
6.9%
6/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/88 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
5.7%
5/87 • 28 Weeks
All reported adverse events were treatment-emergent, defined as investigator-reported events starting on or after the first dose of study drug and up to and including 28 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Cytokinetics agreement with investigators vary; constant is Cytokinetics' right to review communications regarding trial results prior to public release. Cytokinetics does not prohibit investigators from publishing, but single-center publications must be postponed until after release of the first multi-center publication for the trial. Investigators may not disclose previously undisclosed confidential information other than study data and results from their site.
- Publication restrictions are in place
Restriction type: OTHER