HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools

Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials

Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups

Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups

Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data

1. Total number of responses to the question including the proportions of correct answers to questions where appropriate
2. Number or frequency and proportion of response options selected
3. Percentage of responses/total responses per option
4. Mean value and standard deviation (for appropriate questions)

From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed

For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show:

1. Total of number of participants answering the question.
2. Proportions of participants providing correct answers (to identify knowledge and comprehension)
3. Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.
4. Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.

Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)