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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This systematic literature review will include randomized clinical trials (RCTs), case reports, observational studies published in peer reviewed journals, as well as RCTs and observational studies published as abstracts and/or posters at conferences

Study drug and medical condition

• Name of medicine:
  XGEVA
• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB
• Medical condition to be studied:
  Bone giant cell tumour

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The objective of this systematic review is to evaluate published evidence on the safety and clinical effectiveness of XGEVA among mainland Chinese and Chinese patients in Taiwan, Hong Kong, and Macau with GCTB, and to characterize the benefit-risk profile associated with use of this drug in these Chinese GCTB patients, in context of the global body of evidence of XGEVA treated GCTB patients.
• Data analysis plan:
  A qualitative synthesis of results will be performed, and a narrative summary provided in the text of the final report.

Documents

Study results

20220044_ORSR Abstract_28MAR2023_Redacted