Comparison · NCT04704050-sae
Treatment Group vs Control Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Treatment Group vs Control Group: serious adverse events. Trial comparisons, record NCT04704050-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04704050-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 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk in group 2 | 0.3 | 0.108 | 0.603 | wilson | |
| Risk difference, group 1 minus group 2 | -0.133 | -0.459 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.556 | 0.114 | 2.7 | log | |
| Odds ratio, group 1 over group 2 | 0.467 | 0.0611 | 3.56 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Group than on Control Group | 7.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment Group | Dronedarone 400 mg orally, twice per day (BID)~dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.~Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks. | 2 | 12 | EG000 |
| Group 2 | Control Group | Placebo tablet orally, twice per day (BID)~Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks. | 3 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 13 Months
Source ClinicalTrials.gov
Trial
- Title
- Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
- NCT number
- NCT04704050
- Phases
- PHASE4
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Recurrent
- Interventions
- dronedarone 400 mg Oral Tablet, Placebo
- Lead sponsor
- Tulane University School of Medicine
- Results first posted
- 2025-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04704050?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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