Comparison · NCT00489736-sae
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: 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 400mg Bid vs Amiodarone 600mg/200mg od: serious adverse events. Trial comparisons, record NCT00489736-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00489736-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 | 0.137 | 0.0994 | 0.185 | wilson | |
| Risk in group 2 | 0.145 | 0.107 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00855 | -0.0696 | 0.0528 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.941 | 0.611 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 0.932 | 0.564 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dronedarone 400mg Bid than on Amiodarone 600mg/200mg od | 117 | 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 | Dronedarone 400mg Bid | dronedarone tablets 400mg twice daily (bid) | 34 | 249 | EG000 |
| Group 2 | Amiodarone 600mg/200mg od | amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od) | 37 | 255 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first to last study drug intake +10 days i.e. end of the study.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
- NCT number
- NCT00489736
- Phases
- PHASE3
- Conditions
- Atrial Fibrillation
- Interventions
- dronedarone (SR33589), amiodarone
- Lead sponsor
- Sanofi
- Results first posted
- 2009-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00489736?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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