Ipilimumab 12-month intensive pharmacovigilance protocol

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Intensive pharmacovigilance

Study drug and medical condition

• Name of medicine:
  YERVOY
• Medical condition to be studied:
  Acral lentiginous melanoma stage IV

Population studied

• Short description of the study population:
  All patients in Venezuela treated with ipilimumab for advanced (unresectable, recurrent or metastatic melanoma).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

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

      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  35

Study design details

• Main study objective:
  The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatmentwith ipilimumab for advanced melanoma in Venezuela during the protocol period.
• Outcomes:
  AEs reported while on ipilimumab will be recorded during the protocolduration.
• Data analysis plan:
  The protocol is designed as a descriptive analysis. All variables will be analyzed descriptively, and presented as monthly line listing reports and a final report as per the request of the Venezuelan HA.