Comparison · NCT01874665-sae
Cohort A vs Cohort B: 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. Cohort A vs Cohort B: serious adverse events. Trial comparisons, record NCT01874665-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01874665-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 | 0.667 | 0.488 | 0.808 | wilson | |
| Risk in group 2 | 0.4 | 0.198 | 0.643 | wilson | |
| Risk difference, group 1 minus group 2 | 0.267 | -0.0347 | 0.513 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.853 | 3.26 | log | |
| Odds ratio, group 1 over group 2 | 3 | 0.833 | 10.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort A than on Cohort B | 3.75 | 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 | Cohort A | Participants with KIT exon 11-mutant GIST ponatinib: 45 mg, taken orally once-daily. | 20 | 30 | EG000 |
| Group 2 | Cohort B | Participants with GIST that lack KIT exon 11 mutations (Cohort B) ponatinib: 45 mg, taken orally once-daily. | 6 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to 3 years)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
- NCT number
- NCT01874665
- Phases
- PHASE2
- Conditions
- GIST
- Interventions
- Ponatinib
- Lead sponsor
- Ariad Pharmaceuticals
- Results first posted
- 2016-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01874665?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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