Comparison · NCT00978731-2716ed8e
Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry vs Participants With CML: BID Dosing at Study Entry: Number of Participants With Major Cytogenetic Response (MCyR)
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. Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry vs Participants With CML: BID Dosing at Study Entry: Number of Participants With Major Cytogenetic Response (MCyR). Trial comparisons, record NCT00978731-2716ed8e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00978731-2716ed8e
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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 | 0.591 | 0.387 | 0.767 | wilson | |
| Risk in group 2 | 0.6 | 0.357 | 0.802 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00909 | -0.296 | 0.291 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.985 | 0.574 | 1.69 | log | |
| Odds ratio, group 1 over group 2 | 0.963 | 0.253 | 3.67 | log | |
| Number needed to treat, for one fewer participant with the outcome on Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry than on Participants With CML: BID Dosing at Study Entry | 110 | 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 | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time. | 13 | 22 | OG000 |
| Group 2 | Participants With CML: BID Dosing at Study Entry | Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time. | 9 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Major Cytogenetic Response (MCyR)
- Description
Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.
- Time frame
- Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.
- Population
All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.
Source ClinicalTrials.gov
Trial
- Title
- Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study
- NCT number
- NCT00978731
- Phases
- PHASE1
- Conditions
- Leukemia
- Interventions
- Dasatinib
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2011-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00978731?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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