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
First published:
21/02/2024
Institution
Multiple centres: 20 centres are involved in the study

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
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