Safety And Efficacy Of Bosutinib

Completed

• Conditions: Chronic Myelogenous Leukemia
• Interventions: Drug: Bosutinib

• Registration Number: NCT02501330
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bosutinib	Bosutinib	-

Primary Outcome Measures

Name	Time	Method
Cytogenetic response	24 weeks
The incidence of adverse drug reactions	24 weeks