Comparison · NCT02551094-sae
Colchicine vs Colchicine 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. Colchicine vs Colchicine Placebo: serious adverse events. Trial comparisons, record NCT02551094-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02551094-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 | 0.164 | 0.15 | 0.18 | wilson | |
| Risk in group 2 | 0.172 | 0.157 | 0.188 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00783 | -0.0293 | 0.0136 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.84 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.946 | 0.811 | 1.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Colchicine than on Colchicine Placebo | 128 | 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 | Colchicine | 0.5 mg tablet of colchicine taken once a day~colchicine: 0.5 mg tablet taken once a day | 383 | 2,330 | EG001 |
| Group 2 | Colchicine Placebo | 0.5 mg tablet of placebo taken once a day~colchicine placebo: sugar pill manufactured to mimic colchicine 0.5 mg tablet | 404 | 2,346 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The time period covered was from randomization to last follow up which lasted 3.5 years.
Source ClinicalTrials.gov
Trial
- Title
- Colchicine Cardiovascular Outcomes Trial (COLCOT)
- NCT number
- NCT02551094
- Phases
- PHASE3
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Interventions
- colchicine, colchicine placebo
- Lead sponsor
- Montreal Heart Institute
- Results first posted
- 2020-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02551094?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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