A Cross-sectional Survey to Evaluate Patient Knowledge of Safety Messages Included in the Patient Safety Brochure and Patient Alert Card for IMLYGIC®

Study type

• Study topic:
  Human medicinal product

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX51) talimogene laherparepvec

  talimogene laherparepvec
• Medical condition to be studied:
  Malignant melanoma stage III

Population studied

• Short description of the study population:
  The target population is patients who receive IMLYGIC in Germany and the Netherlands.
• 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:
  50

Study design details

• Main study objective:
  The primary objective is to evaluate patients’ knowledge levels of the key messages included in the IMLYGIC Patient Safety Brochure among patients who receive IMLYGIC.
• Outcomes:
  The primary endpoints are the percentages of patients with correct responses to the knowledge-related questions. Success criteria for the primary endpoint percentages are at least 60% of patients provide a correct response to each individual knowledge-related question that has a minimum n = 30. The secondary endpoints are the percentages of patients that report receiving, reading, and using the IMLYGIC Patient Safety Brochure and Patient Alert Card.
• Data analysis plan:
  The primary analysis population will include all patients who have completed at least 1 of the endpoint questions in the survey. Frequencies, percentages, and corresponding 95% confidence intervals (CIs) will be used to summarise the endpoints for the primary analysis set overall, by country, and by subgroups. For each knowledge level question, the percentage of patients who answer each question correctly will be estimated and assessed against the 60% (± 95% CI) target. For secondary endpoints, percentages and 95% CI will be estimated. The primary analysis will be performed by having read vs. not read the IMLYGIC Patient Safety Brochure. An analysis to evaluate the impact of recall bias will be performed by repeating the primary analysis stratified by tertiles of time since patients first received IMLYGIC to when they completed the survey.