Characterization of the metastatic melanoma population in Chile that received ipilimumab for the treatment of unresectable or metastatic melanoma

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Basal features of melanoma patients treated with ipilimumab
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-randomised clinical trial, Retrospective medical records review

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:
  Metastatic melanoma patients who received ipilimumab for MM, in Chile from January 2011 through January 2013.
• Age groups:
  Adults (18 to < 46 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Metastatic melanoma patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The primary objective of the study is to characterize the metastatic melanoma (MM) population, inChile, that received ipilimumab for the treatment of unresectable or MM.
• Outcomes:
  Descriptions of study variables requested by the MoH are provided below:AgeGenderEAP/PrivateDiagnosisStagePerformance StatusPrevious Treatment LinesFirst Infusion dateIpilimumab doseNumber of infusionsRe-inductionFollow-upAdverse EventDate of death
• Data analysis plan:
  All study variables will be analyzed descriptively.This study was not required by any local Health Authority (not mandatory).