Table 1 Specifications and considerations relevant for the data collection

1

Specify at which medication class level the index medication will be collected. Is the ADR caused by a group of medication or an individual medication?

2

Specify at which medication class level the marker medication will be collected. Is the ADR treated by one individual medication or a medication group or with medication from different medication groups?

3

Specify which combination products will be included in the data collection for the index and/or marker medication.

4

Specify how it will be ensured that the patients have sufficient history and follow-up data. Which additional data will be used to ascertain continuous enrollment?

5

Consider characteristics of the ADR, such as the possible dose-relatedness of the ADR and when the ADR generally occurs to inform decisions on subgroup analysis and time windows.

6

Consider patient characteristics that might influence the development of the ADR (e.g. sex, age or comorbidities) to inform patient inclusion or subgroup analysis.

7

Consider co-medication that might influence the development of the ADR to inform patient inclusion or subgroup analysis.