Table 1.

Criteria used to classify reports as “useful” for manual evaluation

Criterion	Description
1	The suspect product of drug ineffective was clearly identifiable
2	An informative narrative to support the reported drug ineffectiveness AND one or more of the following four criteria:
3	MedDRA preferred term(s) in addition to “drug ineffective” was reported
4	Suspect product’s batch or lot number was reported
5	A beneficial response prior to the administration of the suspect product was reported
6	Medication switching was reported

MedDRA Medical Dictionary for Regulatory Activities