A Non-Interventional Post-Authorization Safety Study (NI-PASS) as an effectiveness check of a Patient Card for Padcev™

Study type

• Study topic:
  Herbal 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:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  PADCEV
• Study drug International non-proprietary name (INN) or common name:
  ENFORTUMAB VEDOTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX13) enfortumab vedotin

  enfortumab vedotin

Population studied

• Short description of the study population:
  The study population will be patients in 7 European countries (France, Germany, Italy, Poland, Spain, Sweden, and Switzerland) with locally advanced or metastatic urothelial carcinoma who previously received platinum and PD-1/L1 inhibitor therapy and have received or are currently receiving Padcev™ therapy. If a patient is unable to participate in the survey, their caregiver will be asked to participate.
• 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:
  62

Study design details

• Study design:
  This is a multi-national, non-interventional, cross-sectional survey study with primary data collection to evaluate the effectiveness of patient education materials for Padcev™ (the Padcev™ PC).
• Main study objective:
  The objectives of this NI-PASS are to assess patients’ (or caregivers’) knowledge of the risk of skin reactions associated with the use of Padcev™, as well as awareness of the Padcev™ Patient Card (PC), knowledge of the content of the PC, and reported behaviors to minimise the risk of skin reaction.
• Outcomes:
  - Knowledge levels of patients, or their caregivers, of the risk of skin reactions associated with the use of Padcev™, ; - Knowledge of the symptoms and recommended care for skin reactions associated with the use of Padcev™ ; - Knowledge levels of patients, or their caregivers, of the symptoms and recommended care for skin reactions associated with the use of Padcev™ ; - Reported behaviors of patients, or their caregivers, to minimise the risk associated with the use of Padcev™.
• Data analysis plan:
  A statistical analysis plan will be developed to describe all planned analyses in detail, along with shells for variable lists, tables and figures. ; All analyses will be performed using SAS® V9.0 or later. ; A final report summarizing the results of the survey will be developed. ; The study population included in the data analysis will include patients/caregivers who completed the question in the survey associated with the primary endpoint. ; A threshold of success for the primary endpoints is to have 80% or more patients/caregivers providing a correct response to this question. Descriptive data analyses will be conducted. Levels of awareness and knowledge, self-reported behaviors as well as patient characteristics will be calculated with 95% two-sided Confidence Intervals. Descriptive results will be reported for the overall population of respondents and by country and, if the data permit, for sub-groups such as patients versus caregivers or length of time receiving Padcev™ treatment.