Dimension	Description	Considerations	Penalty (%)
Time-to-onset	Time from treatment start to the suspected ADR	Imprecise information penalised if there is ambiguity as to whether the drug preceded the adverse event; by 30% if the uncertainty exceeds 1 month, 10% otherwise	50
Indication	Indication for treatment with the drug	Penalty imposed if information is missing or cannot be mapped to standard terminologies such as ICD a or MedDRA b	30
Outcome	Outcome of the adverse event in this patient		30
Sex	Patient sex	‘Unknown’ treated as missing	30
Age	Patient’s age at onset of suspected ADR	Age ‘unknown’ treated as missing 10% penalty imposed if only age group is specified	30
Dose	Dose of the drug(s)		10
Country	Country of origin	Supportive in causality assessment since medical practise and adverse reaction reporting vary between countries	10
Primary reporter	Occupation of the person who reported the case (e.g., physician, pharmacist)	Supportive in causality assessment since the interpretation of reported information may differ depending on the reporter’s qualifications	10
Report type	Type of report (e.g., spontaneous report, report from study, other)		10
Comments	Free-text information	Uninformative text snippets excluded	10
a: ICD: International Statistical Classification of Diseases and Related Health Problems; b: MedDRA: Medical Dictionary for Regulatory Activities.