Belzutifan special drug use results survey in radically unresectable or metastatic renal cell carcinoma: a postauthorization safety study (PASS) (MK-6482-045)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive, longitudinal, multi-center collaborative study

Study drug and medical condition

• Medicinal product name:
  WELIREG
• Study drug International non-proprietary name (INN) or common name:
  BELZUTIFAN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX74) belzutifan

  belzutifan
• Medical condition to be studied:
  Renal cell carcinoma

Population studied

• Short description of the study population:
  Patients in Japan with radically unresectable or metastatic RCC (not Von Hippel-Lindau disease (VHL)-associated) who received belzutifan in routine clinical practice for the first time, according to the local Japanese label of belzutifan.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  403

Study design details

• Study design:
  This is a non-interventional, descriptive, longitudinal, multicenter collaborative study in Japan of patients with radically unresectable or metastatic RCC treated with belzutifan.
• Main study objective:
  To evaluate the risk of occurrence of hemorrhages and fractures during the administration of belzutifan in Japanese patients with radically unresectable or metastatic RCC.
• Setting:
  Japanese patients with radically unresectable or metastatic RCC (not VHL-associated), treated with belzutifan for the first time in routine clinical practice according to the local label. Enrollment may occur prospectively at treatment initiation or retrospectively after treatment initiation but before the end of the registration period. There are no comparator arms. Patient and treatment data will be sourced from the patient medical records.
• Comparators:
  There are no comparator arms.
• Outcomes:
  The primary outcomes of interests are:; - Number of participants who experience a hemorrhagic AE; - Number of participants who experience a fracture AE; ;
• Data analysis plan:
  Study endpoints will be analyzed using descriptive statistical methods such as mean, standard deviation, median, interquartile range, and/or minimum/maximum/range for continuous variables. For any categorical variables, e.g., AE analysis, frequency and percentage will be reported. There is no hypothesis testing. To assess whether demographic and/or clinical characteristics impact safety endpoints, these characteristics will be analyzed using descriptive statistical methods and reported for all registered subjects, the safety evaluation group, and presence/absence of AEs/select protocol-specified AEs.