A PROSPECTIVE NON-INTERVENTIONAL SAFETY STUDY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA RECEIVING NILOTINIB IN DAILY PRACTICE ACCORDING TO UPDATED GUIDELINES

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16550
• EU PAS number:
  EUPAS3335
• Study ID:
  16550
• Official title and acronym:
  A PROSPECTIVE NON-INTERVENTIONAL SAFETY STUDY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA RECEIVING NILOTINIB IN DAILY PRACTICE ACCORDING TO UPDATED GUIDELINES
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany
• Study description:
  This non-interventional, observational study will provide real-world safety data on CML CP patients exposed to nilotinib and therefore provide insights into disease management as well as the safety profile of nilotinib.
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 15 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 10/02/2013

Actual: 10/02/2013

Study start date

Planned: 26/08/2013

Actual: 10/10/2013

Data analysis start date

Planned: 01/07/2020

Actual: 31/12/2015

Date of final study report

Planned: 31/12/2016

Actual: 31/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

Study protocol

Initial protocol

CAMN107AAT01_Tasigna_PASS_Protocol_version01_Redacted

Regulatory

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

Other study registration identification numbers and links

CAMN107AAT01