Comparison · NCT04501614-sae
Ponatinib 30 mg Adult-Equivalent vs Ponatinib 15 mg Adult-Equivalent: 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 30 mg Adult-Equivalent vs Ponatinib 15 mg Adult-Equivalent: serious adverse events. Trial comparisons, record NCT04501614-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04501614-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 | 0.714 | 0.359 | 0.918 | wilson | |
| Risk in group 2 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk difference, group 1 minus group 2 | 0.214 | -0.284 | 0.619 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 0.482 | 4.23 | log | |
| Odds ratio, group 1 over group 2 | 2.5 | 0.194 | 32.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ponatinib 30 mg Adult-Equivalent than on Ponatinib 15 mg Adult-Equivalent | 4.67 | 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 | Ponatinib 30 mg Adult-Equivalent | Participants received weight-based dose of ponatinib tablets 30 mg adult-equivalent, orally, once daily in combination with chemotherapy backbone per standard regimen at the investigator's discretion in both reinduction block and consolidation block (35 days each including 29 days of treatment in combination with chemotherapy followed by a minimum 6-day rest period from chemotherapy with daily ponatinib only) up to Day 70 (end of consolidation) followed by optional ponatinib continuation in Phase 1. | 5 | 7 | EG000 |
| Group 2 | Ponatinib 15 mg Adult-Equivalent | Participants received weight-based dose of ponatinib tablets 15 mg adult-equivalent, orally, once daily in combination with chemotherapy backbone per standard regimen at the investigator's discretion in both reinduction block and consolidation block (35 days each including 29 days of treatment in combination with chemotherapy followed by a minimum 6-day rest period from chemotherapy with daily ponatinib only) up to Day 70 (end of consolidation) followed by optional ponatinib continuation in Phase 1. | 2 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 34.8 months in Phase 1
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT04501614
- Phases
- PHASE1, PHASE2
- Conditions
- Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL), Philadelphia Chromosome-Like ALL (Ph-like ALL)
- Interventions
- Ponatinib, Chemotherapy Agents
- Lead sponsor
- Takeda
- Results first posted
- 2025-01-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04501614?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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