Comparison · NCT04971226-398b3127
Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)
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 (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum). Trial comparisons, record NCT04971226-398b3127. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04971226-398b3127
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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 | 0.693 | 0.597 | 0.775 | wilson | |
| Risk in group 2 | 0.402 | 0.312 | 0.499 | wilson | |
| Risk difference, group 1 minus group 2 | 0.291 | 0.155 | 0.412 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.72 | 1.32 | 2.26 | log | |
| Odds ratio, group 1 over group 2 | 3.36 | 1.88 | 6 | log | |
| Number needed to treat, for one more participant with the outcome on Asciminib (Imatinib Stratum) than on Investigator Selected TKI (Imatinib Stratum) | 3.44 | 2.42 | 6.46 | 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 (Imatinib Stratum) | Patients took asciminib 80 mg QD under fasting conditions on ongoing basis. | 70 | 101 | OG000 |
| Group 2 | Investigator Selected TKI (Imatinib Stratum) | Patients took on ongoing basis the Investigator selected TKI (imatinib) | 41 | 102 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)
- Description
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/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 IMA Full Analysis Set (FASIMA) comprised of all participants from the FAS, whose PRS TKI is imatinib. 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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