Safety And Efficacy Of Bosutinib
NCT02501330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 702
Last updated 2024-04-30
Summary
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
- Chronic Myelogenous Leukemia
Interventions
- DRUG
-
Bosutinib
The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Eligibility
- Min Age
- 0 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-01
- Primary Completion
- 2024-02-28
- Completion
- 2024-02-28
Countries
- Japan
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