Comparison · NCT03447990-8df630b8
SAD Cohorts vs MAD Cohorts: Number of Participants With Clinically Significant Laboratory Abnormalities
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. SAD Cohorts vs MAD Cohorts: Number of Participants With Clinically Significant Laboratory Abnormalities. Trial comparisons, record NCT03447990-8df630b8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03447990-8df630b8
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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 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk in group 2 | 0.025 | 0.00443 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0583 | -0.066 | 0.33 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.33 | 0.225 | 49.4 | log | |
| Odds ratio, group 1 over group 2 | 3.55 | 0.205 | 61.4 | log | |
| Number needed to treat, for one more participant with the outcome on SAD Cohorts than on MAD Cohorts | 17.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SAD Cohorts | SAD cohorts Placebo and Danicamtiv at doses ranging from 175 mg to 550 mg | 1 | 12 | OG000 |
| Group 2 | MAD Cohorts | MAD cohorts Placebo and Danicamtiv doses ranging from 50 mg to 100 mg | 1 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Laboratory Abnormalities
- Description
- Number of participants with clinically significant laboratory abnormalities.
- Time frame
- From first dose to 30 days post last dose (Up to 2 months)
- Population
- Pre-specified for data to be collected by combining all treated participants per SAD and MAD Cohort only
Source ClinicalTrials.gov
Trial
- Title
- v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
- NCT number
- NCT03447990
- Phases
- PHASE1, PHASE2
- Conditions
- Heart Failure With Reduced Ejection Fraction, Dilated Cardiomyopathy
- Interventions
- MYK-491, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2023-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03447990?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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