Comparison · NCT01198873-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 NCT01198873-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01198873-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 | 0.143 | 0.0626 | 0.294 | wilson | |
| Risk in group 2 | 0.0244 | 0.00432 | 0.126 | wilson | |
| Risk difference, group 1 minus group 2 | 0.118 | -0.011 | 0.271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.86 | 0.718 | 47.8 | log | |
| Odds ratio, group 1 over group 2 | 6.67 | 0.74 | 60.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dronedarone than on Placebo | 8.44 | 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 | Dronedarone | Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months) | 5 | 35 | EG001 |
| Group 2 | Placebo | Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months) | 1 | 41 | 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 in the period spanning from signature of the Informed Consent Form up to the last visit.
Source ClinicalTrials.gov
Trial
- Title
- Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
- NCT number
- NCT01198873
- Phases
- PHASE4
- Conditions
- Atrial Fibrillation
- Interventions
- Dronedarone, Placebo (for Dronedarone)
- Lead sponsor
- Sanofi
- Results first posted
- 2013-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01198873?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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