Comparison · NCT04971226-3851f304
Asciminib (All Asciminib ) vs Investigator Selected TKI (All Comparators): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
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 (All Asciminib ) vs Investigator Selected TKI (All Comparators): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI. Trial comparisons, record NCT04971226-3851f304. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04971226-3851f304
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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 | 0.677 | 0.609 | 0.737 | wilson | |
| Risk in group 2 | 0.49 | 0.422 | 0.558 | wilson | |
| Risk difference, group 1 minus group 2 | 0.186 | 0.0905 | 0.277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 1.17 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 1.45 | 3.26 | log | |
| Number needed to treat, for one more participant with the outcome on Asciminib (All Asciminib ) than on Investigator Selected TKI (All Comparators) | 5.36 | 3.6 | 11 | 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 | Asciminib (All Asciminib ) | Patients took asciminib 80 mg QD under fasting conditions on ongoing basis. | 136 | 201 | OG000 |
| Group 2 | Investigator Selected TKI (All Comparators) | Patients took on ongoing basis the Investigator selected TKIs (imatinib, nilotinib, dasatinib or bosutinib) | 100 | 204 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
- Description
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
- Time frame
- At 48 weeks
- Population
- The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
- NCT number
- NCT04971226
- Phases
- PHASE3
- Conditions
- Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
- Interventions
- Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2025-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04971226?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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