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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.
Official title: DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
Key Details
Gender
All
Age Range
0 Years - Any
Study Type
OBSERVATIONAL
Enrollment
702
Start Date
2015-07-01
Completion Date
2024-02-28
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
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.