Comparison · NCT03106779-sae
Asciminib vs Bosutinib: 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. Asciminib vs Bosutinib: serious adverse events. Trial comparisons, record NCT03106779-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03106779-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 | 0.135 | 0.0898 | 0.197 | wilson | |
| Risk in group 2 | 0.184 | 0.113 | 0.286 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0496 | -0.161 | 0.0451 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.731 | 0.394 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 0.689 | 0.329 | 1.44 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Asciminib than on Bosutinib | 20.2 | 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 | Asciminib | Patients randomized to asciminib 40mg BID | 21 | 156 | EG000 |
| Group 2 | Bosutinib | Patients randomized to bosutinib 500mg QD | 14 | 76 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
For this interim results, Adverse Events were reported from informed consent (maximum 21 days before randomization) until end of treatment plus 30 days. The maximum duration of treatment exposure was 129.9 weeks for asciminib and 117 weeks for bosutinib.
Source ClinicalTrials.gov
Trial
- Title
- Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
- NCT number
- NCT03106779
- Phases
- PHASE3
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- Asciminib, Bosutinib
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2022-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03106779?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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