Comparison · NCT03447990-e734af93
SAD Cohorts Danicamtiv vs SAD Cohorts Placebo: Number of Participants With a Troponin I Increase - SAD Cohorts
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. SAD Cohorts Danicamtiv vs SAD Cohorts Placebo: Number of Participants With a Troponin I Increase - SAD Cohorts. Trial comparisons, record NCT03447990-e734af93. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03447990-e734af93
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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 | 0.25 | 0.0889 | 0.532 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | 0.25 | -0.0411 | 0.532 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on SAD Cohorts Danicamtiv than on SAD Cohorts Placebo | 4 | 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 | SAD Cohorts Danicamtiv | SAD cohorts at doses ranging from 175 mg to 550 mg | 3 | 12 | OG000 |
| Group 2 | SAD Cohorts Placebo | SAD cohorts with participants that received placebo | 0 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Troponin I Increase - SAD Cohorts
- Description
Number of participants with a troponin increase is defined as when one of the following conditions was met (1) if the participant's troponin I value was normal prior to dosing (≤0.03 ng/mL), an elevated level on at least one measurement after start of dosing \>2×ULN for the specific assay (\>0.06 ng/mL) through Day 16. (2) If the participant's troponin I value was above the ULN for the specific assay prior to dosing, an increase \>0.03 ng/mL compared to baseline on at least one measurement after start of dosing through Day 16.
- Time frame
- Baseline, day 1-3, 2 hours pre-dose and at 3-, 5-, 9-, 12-, 24-, and 36-hours post-dose
- Population
- Pre-specified for data to be collected by combining all treated participants in SAD Cohorts per regimen 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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