Comparison · NCT04349072-sae
Mavacamten 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 vs Placebo: serious adverse events. Trial comparisons, record NCT04349072-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04349072-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 | 0.194 | 0.131 | 0.279 | wilson | |
| Risk in group 2 | 0.0182 | 0.00322 | 0.0961 | wilson | |
| Risk difference, group 1 minus group 2 | 0.176 | 0.0757 | 0.262 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 10.7 | 1.48 | 77.4 | log | |
| Odds ratio, group 1 over group 2 | 13 | 1.7 | 99.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Mavacamten than on Placebo | 5.67 | 3.81 | 13.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Mavacamten | 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). | 21 | 108 | EG000 |
| Group 2 | Placebo | One placebo-to-match mavacamten capsule once daily for 16 weeks. | 1 | 55 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
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.)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
- NCT number
- NCT04349072
- Phases
- PHASE3
- Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy
- Interventions
- Mavacamten, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2023-03-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04349072?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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