Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors among Chronic Myeloid Leukemia Patients

Study identification

• EU PAS number:
  EUPAS50308
• Study ID:
  50309
• Official title and acronym:
  Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors among Chronic Myeloid Leukemia Patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant’s condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. No new data will be collected from participants as part of this study and no study medicines will be provided in this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 06/10/2021

Study start date

Actual: 24/07/2020

Data analysis start date

Actual: 24/07/2020

Date of interim report, if expected

Actual: 22/12/2021

Date of final study report

Actual: 30/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable