Status: OngoingLast updated on: 24/01/2019
1. Study identification
EU PAS Register NumberEUPAS9097
Official titleA 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 title acronymOMNI
Study typeObservational study
Brief description of the studyA 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)
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameARIAD Pharmaceuticals, Inc (a wholly-owned subsidiary of Takeda Pharmaceuticals Company Limited)
Centre locationCambridge, MA, USA
Details of (Primary) lead investigator
Title Ms
Last name Stemhagen
First name Annette
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/11/2014
Start date of data collection01/12/201610/04/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report02/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesARIAD Pharmaceuticals, Inc (a wholly-owned subsidiary of Takeda Pharmaceuticals Company Limited)100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Stemhagen
First name Annette
Address line 1United Biosource, LLC (UBC)
Address line 2920 Harvest Drive, Suite 200 
Address line 3 
CityBlue Bell, PA 
Postcode19422 
CountryUnited States
Phone number (incl. country code)12155912880 
Alternative phone number 
Fax number (incl. country code) 
Email address OMNIRegistry@ubc.com
Public Enquiries
Title Ms 
Last name Stemhagen 
First name Annette 
Address line 1United Biosource, LLC (UBC) 
Address line 2920 Harvest Drive, Suite 200 
Address line 3 
CityBlue Bell, PA 
Postcode19422 
CountryUnited States 
Phone number (incl. country code)12155912880 
Alternative phone number 
Fax number (incl. country code) 
Email address OMNIRegistry@ubc.com 
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