Comparison · NCT00489736-7bd483ff
Dronedarone 400mg Bid vs Amiodarone 600mg/200mg od: Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting
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: Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting. Trial comparisons, record NCT00489736-7bd483ff. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00489736-7bd483ff
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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 | 0.245 | 0.196 | 0.302 | wilson | |
| Risk in group 2 | 0.388 | 0.331 | 0.449 | wilson | |
| Risk difference, group 1 minus group 2 | -0.143 | -0.222 | -0.0621 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.631 | 0.483 | 0.824 | log | |
| Odds ratio, group 1 over group 2 | 0.511 | 0.349 | 0.75 | log | |
| Number needed to treat, for one fewer participant with the outcome on Dronedarone 400mg Bid than on Amiodarone 600mg/200mg od | 6.98 | 4.51 | 16.1 | from the risk difference interval |
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) | 61 | 249 | OG000 |
| Group 2 | Amiodarone 600mg/200mg od | amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od) | 99 | 255 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting
- Description
The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
- Time frame
- minimum study duration is 6 months (+10 days); maximum is 15 months
- Population
- All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.
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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