Postmarketing Surveillance Study of XGEVA (Denosumab) in South Korea (20160198)

Study identification

• EU PAS number:
  EUPAS18114
• Study ID:
  40681
• Official title and acronym:
  Postmarketing Surveillance Study of XGEVA (Denosumab) in South Korea (20160198)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  The primary objective of this study is to estimate the incidence of adverse events, serious adverse events, and adverse drug reactions among patients receiving XGEVA® in a postmarketing setting as required by the Ministry of Food and Drug Safety.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/08/2016

Actual: 29/08/2016

Study start date

Planned: 13/10/2017

Actual: 24/10/2017

Data analysis start date

Planned: 14/08/2020

Actual: 13/08/2020

Date of interim report, if expected

Planned: 28/11/2019

Date of final study report

Planned: 16/04/2021

Actual: 22/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

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