Comparison · NCT02130557-9a19fce3
Bosutinib vs Imatinib: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Bosutinib vs Imatinib: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities. Trial comparisons, record NCT02130557-9a19fce3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02130557-9a19fce3
On this page
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 | 0.0602 | 0.0374 | 0.0955 | wilson | |
| Risk in group 2 | 0.0496 | 0.0292 | 0.083 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0105 | -0.0299 | 0.0513 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.595 | 2.47 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.578 | 2.6 | log | |
| Number needed to treat, for one more participant with the outcome on Bosutinib than on Imatinib | 94.9 | 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. | 16 | 266 | 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. | 13 | 262 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
- Description
Criteria for ECG abnormalities included heart rate: increase of \>15 bpm from baseline value and \>=120 bpm, decrease of \>15 bpm from baseline value and \<=45 bpm; PR interval: change of \>=20 msec from baseline value and \>=220 milliseconds (msec); QRS interval \>=120 msec; QTcB interval \>500 msec, increase of \>60 msec from baseline; \>450 msec (Men) or \>470 msec (Women). QT interval using Fridericia's correction (QTcF) \>500 msec, increase of \>60 msec from baseline, \>450 msec (Men) or \>470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02130557-9a19fce3