Table 5.

Survey Responses about Incorporation of General Toxicity Endpoints on DART Studies

Fertility study		Clinical Pathology				Organ weights				Histopathology
		Yes	aMaybe	No	Total	Yes	Maybe	No	Total	Yes	Maybe	No	Total
Male
Rodent	#	6	21	10	37	29	7	3	39	16	18	4	38
	%	16	57b	27		74	18	8		42	47	11
NHP	#	5	11	6	22	14	6	4	24	11	6	6	23
	%	23	50	27		58	25	17		48	26	26
Female
Rodent	#	6	21	10	37	22	8	8	38	13	18	6	37
	%	16	57	27		58	21	21		35	49	16
NHP	#	5	11	7	23	12	7	5	24	10	6	7	23
	%	22	48	30		50	29	21		44	26	30

EFD study		Clinical Pathology				Organ weights				Histopathology
		Yes	Maybe	No	Total	Yes	Maybe	No	Total	Yes	Maybe	No	Total
Dam
Rodent	#	5	22	10	37	8	15	15	38	7	22	8	37
	%	14	60	27		21	40	40		19	60	22
NHP	#	4	13	8	25	4	12	9	25	3	13	9	25
	%	16	52	32		16	48	36		12	52	36
Fetus
Rodent	#	1	9	25	35	4	10	24	38	2	17	17	36
	%	3	26	71		11	26	63		6	47	47
NHP	#	0	9	16	25	7	9	9	25	3	13	9	25
	%	0	36	64		28	36	36		12	52	36

PPND study		Clinical Pathology				Organ weights				Histopathology
		Yes	Maybe	No	Total	Yes	Maybe	No	Total	Yes	Maybe	No	Total
Dam
Rodent	#	4	20	12	36	10	12	16	38	6	17	13	36
	%	11	56	33		26	32	42		17	47	36
NHP	#	7	14	5	26	6	8	12	26	2	14	10	26
	%	27	54	19		23	31	46		8	54	39
Pup
Rodent	#	2	13	19	34	7	15	16	38	7	19	10	36
	%	6	38	56		18	40	42		19	53	28
NHP	#	8	8	9	25	10	10	7	27	8	12	5	25
	%	32	32	36		37	37	26		32	48	20

^aMaybe represents both “triggered by previous observations” & “potential consequences of pharmacological target modulation” (combining these was based on feedback from the respondents’ comments)

^bBold denotes largest bucket for that category