Comparison · NCT03470545-sae
Mavacamten (MYK-461) vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Mavacamten (MYK-461) vs Placebo: serious adverse events. Trial comparisons, record NCT03470545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03470545-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.114 | 0.069 | 0.182 | wilson | |
| Risk in group 2 | 0.0938 | 0.0544 | 0.157 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0201 | -0.0572 | 0.0988 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.585 | 2.52 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.55 | 2.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Mavacamten (MYK-461) than on Placebo | 49.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Mavacamten (MYK-461) | mavacamten: mavacamten capsules~One mavacamten 2.5, 5, 10, or 15 mg capsule once daily by mouth for 30 weeks. The starting dose of mavacamten was 5 mg once daily by mouth. At Week 6, Week 8, and Week 14, mavacamten dose may have been up-titrated or down-titrated for individual subjects based on prespecified criteria. | 14 | 123 | EG000 |
| Group 2 | Placebo | Placebo: placebo oral capsule~One placebo-to-match mavacamten capsule once daily by mouth for 30 weeks. A universal placebo capsule to match all strengths of mavacamten had the same appearance as mavacamten capsules but did not include the active ingredient. Placebo dose to match mavacamten capsule was administered once daily by mouth. | 12 | 128 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-Emergent Adverse Events (TEAEs) were summarized for the on-treatment period (Day 1 to Week 30) and for the treatment-emergent period (Day 1 to Week 38).
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- NCT number
- NCT03470545
- Phases
- PHASE3
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Interventions
- mavacamten, Placebo
- Lead sponsor
- MyoKardia, Inc.
- Results first posted
- 2021-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03470545?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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