Safety And Efficacy Of Bosutinib

Pfizer702 enrolled

Overview

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.

The patients should be registered by central registration system.

Study Type

OBSERVATIONAL

Enrollment

702

Conditions

Chronic Myelogenous Leukemia

Interventions

BosutinibDRUG

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.

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of adverse drug reactions

Time frame: 24 weeks

Cytogenetic response

Time frame: 24 weeks

Data from ClinicalTrials.gov

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