Comparison · NCT01650805-sae
Ponatinib 45 mg vs Imatinib 400 mg: 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. Ponatinib 45 mg vs Imatinib 400 mg: serious adverse events. Trial comparisons, record NCT01650805-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01650805-sae
On this page
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 | 0.318 | 0.25 | 0.395 | wilson | |
| Risk in group 2 | 0.0855 | 0.0507 | 0.141 | wilson | |
| Risk difference, group 1 minus group 2 | 0.233 | 0.145 | 0.317 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.72 | 2.11 | 6.57 | log | |
| Odds ratio, group 1 over group 2 | 4.99 | 2.57 | 9.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ponatinib 45 mg than on Imatinib 400 mg | 4.3 | 3.15 | 6.91 | from the risk difference interval |
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 | Ponatinib 45 mg | ponatinib: 45 mg tablet, taken orally once daily | 49 | 154 | EG000 |
| Group 2 | Imatinib 400 mg | imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily | 13 | 152 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Patients were followed-up for AEs from the time of informed consent until 30 days after the close of the trial. The median follow-up was 4.97 months (range: 0.03, 17.57) for ponatinib patients, and 5.32 months (range: 0.49, 14.05) for imatinib patients.
Source ClinicalTrials.gov
Trial
- Title
- Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
- NCT number
- NCT01650805
- Phases
- PHASE3
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- ponatinib, imatinib (Gleevec/ Glivec)
- Lead sponsor
- Ariad Pharmaceuticals
- Results first posted
- 2014-10-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01650805?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01650805-sae