Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cross-sectional
Population studied

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

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.