Risk Evaluation and Mitigation Strategy (REMS) Assessment Protocol - Zydelig (idelalisib) tablets (Zydelig REMS KAB)

Study identification

• EU PAS number:
  EUPAS11551
• Study ID:
  20922
• Official title and acronym:
  Risk Evaluation and Mitigation Strategy (REMS) Assessment Protocol - Zydelig (idelalisib) tablets (Zydelig REMS KAB)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Knowledge attitude and behavior (KAB) survey of Zydelig REMS safety messages in the US.
• Study status:
  Finalised

Research institutions and networks

Institutions

BioTrak Research Inc.

Study timelines

Date when funding contract was signed

Actual:21/01/2015

Study start date

Actual:21/07/2015

Data analysis start date

Actual:06/11/2015

Date of final study report

Planned:15/12/2015

Actual:04/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable