Clinical trial · Observational
Safety And Efficacy Of Bosutinib
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
NCT02501330CI-TRIAL-00117522BLFcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Bosutinib
- interventionNames
- Drug: Bosutinib
Primary outcomes (2)
- measure
- The incidence of adverse drug reactions
- timeFrame
- 24 weeks
- measure
- Cytogenetic response
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug * Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug Exclusion Criteria: * Patients with a history of hypersensitivity * Women who may possibly be pregnant or become pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.