Ipilimumab 12-month intensive pharmacovigilance protocol

Study identification

• EU PAS number:
  EUPAS6033
• Study ID:
  28053
• Official title and acronym:
  Ipilimumab 12-month intensive pharmacovigilance protocol
• DARWIN EU® study:
  No
• Study countries:
  Venezuela, Bolivarian Republic of
• Study description:
  This protocol is being conducted to comply with the direct request from the HA for a 12-month intensive pharmacovigilance protocol of all patients in Venezuela treated with ipilimumab for advanced (unresectable, recurrent or metastatic melanoma). The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatmentwith ipilimumab for advanced melanoma in Venezuela during the protocol period of 12 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

JSS Medical Research Inc, Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:10/12/2013

Actual:10/12/2013

Study start date

Actual:10/02/2014

Data analysis start date

Actual:15/05/2015

Date of interim report, if expected

Actual:10/09/2015

Date of final study report

Planned:02/04/2015

Actual:28/01/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)