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- 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
- Patients with a history of hypersensitivity
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Descriptive Information | |||||
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Brief Title | Safety And Efficacy Of Bosutinib | ||||
Official Title | DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN) | ||||
Brief Summary | The objective of this surveillance is to collect information about
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Detailed Description | The patients should be registered by central registration system. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | The patients who have been treated with Bosutinib | ||||
Condition | Chronic Myelogenous Leukemia | ||||
Intervention | Drug: 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. Other Name: BOSULIF | ||||
Study Groups/Cohorts | Bosutinib
Intervention: Drug: Bosutinib | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 659 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | August 7, 2023 | ||||
Estimated Primary Completion Date | August 7, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02501330 | ||||
Other Study ID Numbers | B1871036 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | December 2020 |