A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG® (ponatinib) in Routine Clinical Practice in the US (OMNI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45170
• EU PAS number:
  EUPAS9097
• Study ID:
  45170
• Official title and acronym:
  A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG® (ponatinib) in Routine Clinical Practice in the US (OMNI)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  A Post-marketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated with Iclusig® (Ponatinib) in Routine Clinical Practice in the US (OMNI – Study Number AP24534-14-401)
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 07/11/2014

Study start date

Planned: 01/12/2016

Actual: 02/03/2018

Data analysis start date

Actual: 19/02/2019

Date of final study report

Planned: 30/11/2021

Actual: 03/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ARIAD Pharmaceuticals, Inc (a wholly-owned subsidiary of Takeda Pharmaceuticals Company Limited)

Study protocol

Initial protocol

Redacted AP24534-14-401 OMNI Protocol Amendment 4, v5.0

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)