Chronic Myelogenous Leukemia
Conditions
Keywords
Drug use investigation in Japan
Brief 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.
Detailed description
The patients should be registered by central registration system.
Interventions
DRUGBosutinib
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
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse drug reactions | 24 weeks |
| Cytogenetic response | 24 weeks |
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed