Effectiveness, Efficacy, and Safety of XGEVA (denosumab) in Chinese Patients With Giant Cell Tumor of Bone (GCTB): A Systematic Literature Review (20220044)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50352
• EU PAS number:
  EUPAS49061
• Study ID:
  50352
• Official title and acronym:
  Effectiveness, Efficacy, and Safety of XGEVA (denosumab) in Chinese Patients With Giant Cell Tumor of Bone (GCTB): A Systematic Literature Review (20220044)
• DARWIN EU® study:
  No
• Study countries:
  China

  Taiwan

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 22/08/2022

Actual: 22/08/2022

Study start date

Planned: 11/11/2022

Actual: 04/11/2022

Data analysis start date

Planned: 12/12/2022

Actual: 19/12/2022

Date of final study report

Planned: 01/04/2023

Actual: 01/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original denosumab 20220044

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable