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

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NCT02546375

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Royal Liverpool Hospital
Liverpool, Merseyside, L7 8XP United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myeloid Leukaemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prescribed bosutinib as part of an interventional clinical trial programme.

- Initiated on bosutinib less than 3 months prior to data collection taking place.

NCT02546375
Pfizer
Completed
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

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A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
A Retrospective Observational Research Study To Describe The Real World Use Of Bosutinib In The Uk And Netherlands
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
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
CML out-patient clinics
Chronic Myeloid Leukaemia
Drug: Bosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
Other Name: Bosulif
Chronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
Intervention: Drug: Bosutinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2017
January 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02546375
B1871052
No
Not Provided
Not Provided
Pfizer
Pfizer
pH Associates
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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