Comparison · NCT01994226-sae
Low-dose Colchicine vs Naproxen: 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. Low-dose Colchicine vs Naproxen: serious adverse events. Trial comparisons, record NCT01994226-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01994226-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 | 0.00503 | 0.000888 | 0.0279 | wilson | |
| Risk in group 2 | 0.01 | 0.00275 | 0.0357 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00497 | -0.031 | 0.019 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.503 | 0.0459 | 5.5 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.045 | 5.56 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Low-dose Colchicine than on Naproxen | 201 | 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 | Low-dose Colchicine | 500 mcg every eight hours for four days~Low-dose colchicine: Route of Administration: Tablet - Oral Use~Dose: 500 mcg (one tablet) every eight hours for four days | 1 | 199 | EG000 |
| Group 2 | Naproxen | Single initial dose of 750 mg followed by 250 mg every eight hours for up to seven days~Naproxen 750 mg/250 mg: Route of Administration: Tablet - Oral Use~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days | 2 | 200 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 weeks
Source ClinicalTrials.gov
Trial
- Title
- Colchicine Or Naproxen Treatment for ACute gouT
- NCT number
- NCT01994226
- Phases
- PHASE4
- Conditions
- Gout
- Interventions
- Low-dose colchicine, Naproxen 750 mg/250 mg
- Lead sponsor
- Keele University
- Results first posted
- 2018-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01994226?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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