Table 5.

Characteristics of “drug ineffective” reports manually evaluated (N = 552)

Recorded information	Observation	N	%
The suspect product of “drug ineffective” was specified from narrative field	Yes	526	95.3
	No	26	4.7
Suspect product’s type from narrative field	Brand	415	75.2
	Generic	42	7.6
	Both	13	2.4
	Unknown	56	10.2
	NAa	26	4.7
Most frequently identified products (top 3)	Adalimumab	47	8.5
	Etanercept	30	5.4
	Naproxen	19	3.4
Medication switch reported	Yes	34	6.2
	No	518	93.8
A beneficial response to the product’s active ingredient prior to suspect product exposure	Yes	75	13.6
	No	71	12.9
	Not reported/unknown	406	73.6
Suspect product was continued	Yes	78	14.1
	No	164	29.7
	Not reported/unknown	310	56.2
Suspect product’s batch or lot number was reported	Yes	95	17.2
	No	457	82.8
Product application type	NDA	330	60.1
	BLA	106	19.1
	ANDA	42	7.6
	Multiple	1	0.2
	Missing	73	13.1
PT(s) other than “drug ineffective” reported	Yes	327	59.2
	No	225	40.8
Concurrently reported PTs (Top 3)	Fatigue	27	4.9
	Product quality issue	25	4.5
	Off label use	18	3.3
DI report was “useful”	Yes	43	7.8
	No	509	92.2

ANDA abbreviated new drug application, BLA biologics license application, DI drug ineffective, NA not available, NDA new drug application, PTs preferred terms

^aSuspect product’s type was recorded as NA when there was no identifiable suspect product in the narrative field