Comparison · NCT02476279-sae
Indomethacin Alone vs Indomethacin+Pancreatic Stent: 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. Indomethacin Alone vs Indomethacin+Pancreatic Stent: serious adverse events. Trial comparisons, record NCT02476279-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02476279-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 | 0.364 | 0.334 | 0.395 | wilson | |
| Risk in group 2 | 0.361 | 0.331 | 0.392 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00308 | -0.0395 | 0.0457 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.897 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.843 | 1.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Indomethacin Alone than on Indomethacin+Pancreatic Stent | 325 | 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 | Indomethacin Alone | Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement | 355 | 975 | EG000 |
| Group 2 | Indomethacin+Pancreatic Stent | Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement | 352 | 975 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30).
Source ClinicalTrials.gov
Trial
- Title
- Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis
- NCT number
- NCT02476279
- Phases
- PHASE3
- Conditions
- Post-ERCP Pancreatitis
- Interventions
- Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement, Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
- Lead sponsor
- Medical University of South Carolina
- Results first posted
- 2024-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02476279?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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