Comparison · NCT02130557-f4b9e389
Bosutinib vs Imatinib: Number of Participants With Vital Signs Abnormalities
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. Bosutinib vs Imatinib: Number of Participants With Vital Signs Abnormalities. Trial comparisons, record NCT02130557-f4b9e389. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02130557-f4b9e389
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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 | 0.408 | 0.351 | 0.469 | wilson | |
| Risk in group 2 | 0.414 | 0.357 | 0.475 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00605 | -0.0896 | 0.0776 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.985 | 0.803 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.975 | 0.689 | 1.38 | log | |
| Number needed to treat, for one fewer participant with the outcome on Bosutinib than on Imatinib | 165 | 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 | Bosutinib | Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 107 | 262 | OG000 |
| Group 2 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 109 | 263 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Vital Signs Abnormalities
- Description
Criteria for vital signs abnormalities: systolic blood pressure \<80 millimeter of mercury (mmHg), \>210 mmHg; diastolic blood pressure \<40 mmHg, \>130 mmHg; heart rate \<40 beats per minute (bpm), \>150 bpm; temperature \<32 degree celsius, \>40 degree celsius; weight \>=10% increase from baseline, \>=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days.
- Time frame
- Baseline up to end of treatment (up to Month 60)
- Population
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, N signifies number of participants evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
- NCT number
- NCT02130557
- Phases
- PHASE3
- Conditions
- Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
- Interventions
- Bosutinib, Imatinib
- Lead sponsor
- Pfizer
- Results first posted
- 2018-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02130557?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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