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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  To provide descriptive data on the use of XGEVA® incidence of adverse events and adverse drug reactions, incidence of SREs, and patient characteristics in a postmarketing setting
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, observational, multicenter study in patients with approved indications who are being treated with XGEVA®

Study drug and medical condition

• Name of medicine:
  XGEVA
• Medical condition to be studied:
  Metastases to bone

Population studied

• Short description of the study population:
  The study population comprises patients treated with XGEVA in a clinical setting which includes any primary through tertiary healthcare setting where XGEVA is prescribed. Patients will be screened for eligibility, receive a single dose of XGEVA during their initial visit/day 1 (which could be the same day as screening), and return for follow-up visits approximately Q4W for subsequent doses (provided the patient remains on treatment).; ; Inclusion criteria: subjects receiving first dose on day-1 of study; consenting to participate in study and provide medical information.; Exclusion criteria: subjects denying consent; untreated severe hypocalcemia; known hypersensitivity to denosumab/its components.
• Age groups:
  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:
  300

Study design details

• Main study objective:
  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 MFDS.
• Outcomes:
  Incidence of adverse events and adverse drug reactions (including seriousness and causality to drug), inclusive of reaction at local injection sites, will be collected as they become available throughout the follow-up period and reported. Subject level incidence will be reported and summarized by classification according to the adverse event coding, (1) SREs will be assessed either by collecting patient-reported events or through findings as part of routine clinical practice, (2) Describe characteristics of patients receiving XGEVA® in the postmarketing setting.
• Data analysis plan:
  Descriptive analysis of the collected safety and efficacy endpoints will be conducted at interim analyses (every 6 months for the first 2 years from approval, then annually thereafter) and final analysis when all patients have the opportunity to complete the final study visit. Categorical outcomes will be summarized by the number and percentage of subjects in each category. Continuous outcomes will be summarized by the number of nonmissing values, mean, standard deviation, median, lower and upper quartiles, and minimum and maximum values. Kaplan-Meier estimates and their 95% confidence interval (CI) will be provided for time-to-event endpoints. For the incidence, 95% CI will be presented based on an exact method. The analysis will include all enrolled patients (enrollment is triggered once an eligible, consenting patient receives their first dose of XGEVA®).