A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-15

Study Completion Date

2017-01-16

Brief Summary

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The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting

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Detailed Description

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Conditions

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Chronic Myeloid Leukaemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic Myeloid Leukaemia

Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib

Bosutinib

Intervention Type DRUG

Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)

Interventions

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Bosutinib

Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)

Intervention Type DRUG

Other Intervention Names

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Bosulif

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
* Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 OR via the compassionate use programme prior to marketing authorization.
* Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

* Prescribed bosutinib as part of an interventional clinical trial programme.
* Initiated on bosutinib less than 3 months prior to data collection taking place.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No