Ivabradine vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.297 | 0.285 | 0.309 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.326 | 0.314 | 0.339 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0293 | -0.0466 | -0.0119 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.91 | 0.861 | 0.963 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.872 | 0.804 | 0.946 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ivabradine than on Placebo | 34.2 | 21.4 | 84.1 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Ivabradine | Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily. | 1,625 | 5,477 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Patients received placebo twice daily. | 1,770 | 5,430 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | From randomization to death, up to 3 years | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction | ClinicalTrials.gov |
| NCT number | NCT00143507 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Coronary Disease, Ventricular Dysfunction, Left | ClinicalTrials.gov |
| Interventions | Ivabradine, Placebo | ClinicalTrials.gov |
| Lead sponsor | Institut de Recherches Internationales Servier | ClinicalTrials.gov |
| Results first posted | 2015-06-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00143507?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.