Comparison · NCT01151137-sae
Dronedarone 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. Dronedarone vs Placebo: serious adverse events. Trial comparisons, record NCT01151137-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01151137-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 | 0.07 | 0.0586 | 0.0835 | wilson | |
| Risk in group 2 | 0.0479 | 0.0385 | 0.0594 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0222 | 0.00589 | 0.0386 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.46 | 1.1 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 1.11 | 2.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dronedarone than on Placebo | 45.1 | 25.9 | 170 | 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 | Dronedarone | Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days) | 113 | 1,614 | EG001 |
| Group 2 | Placebo | Placebo twice daily until the CSED (median treatment duration of 87.5 days) | 77 | 1,609 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
Source ClinicalTrials.gov
Trial
- Title
- Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
- NCT number
- NCT01151137
- Phases
- PHASE3
- Conditions
- Atrial Fibrillation
- Interventions
- Dronedarone, Placebo (for Dronedarone)
- Lead sponsor
- Sanofi
- Results first posted
- 2012-10-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01151137?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.govNo license 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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