Score Example 2 1. Timing (score 1 if latency is clear, based on date calculation and/or narrative) 0 Drug start date present, and (3-2015; unknown when the first event was) ADR start date present (3-2016) OR Given latency in narrative (1 month); unknown when the last dose was taken) IF BOTH Given latency corresponds to calculated latency (if discrepancy: score 0) 2. Drug (score 1 if all 4 are present) 0 Drug name (rizatriptan) Drug strength (unknown) Dose (as necessary, unknown when and how much the patient took the drug) Indication (migraine) 3. ADR 1 Score 1 if description makes clear what happened; (acute coronary syndrome or myocardial infarction based on coronary dissection not on atherosclerosis) 0 if description is vague, like reaction’ without description of ‘allergic symptoms or localisation; or function abnormal’ without test results ‘liver 4. Outcome (if both present, 1) 0 Action taken (dose reduced, dose not changed, drug withdrawn) (withdrawn) Outcome (recovered, recovering, recovered with sequel, not recovered) (unknown) 5. Additional information 1 if at least 1 is present) 1 Concomitant drugs (present) Medical history (present) Past drug therapy (present) Recurrence Test information 2 Total score Interpretation of the total score: moderatly Well documented > 4 Moderately documented > 2 but <4 Poorly documented <2
Score Example 2 1. Timing (score 1 if latency is clear, based on date calculation and/or narrative) Drug start date present, and (3-2015; unknown when the first event was) ADR start date present (3-2016) OR Given latency in narrative (1 month); unknown when the last dose was taken) IF BOTH Given latency corresponds to calculated latency (if discrepancy: score 0) 0 2. Drug (score 1 if all 4 are present) Drug name (rizatriptan) Drug strength (unknown) Dose (as necessary, unknown when and how much the patient took the drug) Indication (migraine) 0 3. ADR Score 1 if description makes clear what happened; (acute coronary syndrome or myocardial infarction based on coronary dissection not on atherosclerosis) 0 if description is vague, like ‘allergic reaction’ without description of symptoms or localisation; or ‘liver function abnormal’ without test results 1 4. Outcome (if both present, 1) Action taken (dose reduced, dose not changed, drug withdrawn) (withdrawn) Outcome (recovered, recovering, recovered with sequel, not recovered) (unknown) 0 5. Additional information 1 if at least 1 is present) Concomitant drugs (present) Medical history (present) Past drug therapy (present) Recurrence Test information 1 Total score 2 Interpretation of the total score: Well documented > 4 Moderately documented > 2 but <4 Poorly documented <2 moderatly