Comparison · NCT01135017-c0aa4184
Dronedarone vs Placebo: Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)
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: Incidence Rate of Electrical Cardioversion (or Overdrive Pacing). Trial comparisons, record NCT01135017-c0aa4184. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01135017-c0aa4184
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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 | 0 | 0.0653 | wilson | |
| Risk in group 2 | 0.0182 | 0.00322 | 0.0961 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0182 | -0.0961 | 0.0488 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Dronedarone than on Placebo | 55 | 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 for 12 weeks | 0 | 55 | OG001 |
| Group 2 | Placebo | Placebo (for Dronedarone) twice a day for 12 weeks | 1 | 55 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)
- Description
Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.~Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study.
- Time frame
- 12 weeks
- Population
- Modified intent-to-treat population as previously defined
Source ClinicalTrials.gov
Trial
- Title
- Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
- NCT number
- NCT01135017
- Phases
- PHASE4
- Conditions
- Atrial Fibrillation
- Interventions
- Dronedarone, Placebo (for Dronedarone)
- Lead sponsor
- Sanofi
- Results first posted
- 2013-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01135017?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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