Safety And Efficacy Of Bosutinib (BLF)

Pfizer

Status: Completed

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: Bosutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT02501330

B1871036

Details and patient eligibility

About

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.

Full description

The patients should be registered by central registration system.

Enrollment: 702 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

702 participants in 1 patient group

Bosutinib

Treatment:

Drug: Bosutinib