Table 2. Cynomolgus Toxicology Signals with Ipilimumab and Nivolumab Combination.

Group	M/F	Treatment	Dose	Diarrheaa	Mean Spleen Weightb (g)		Spleen Pathologyc	Gastrointestinal Pathologyd
			mg/kg	n/N	Day 30 M/F	Day 59 M/F	n/N	n/N
1	5/5	saline control	—	0/10	3.9/2.8	3.5/3.7	0/6	0/6
2	5/5	nivolumab + ipilimumab	10 3	2/10	4.0/3.6	4.3/2.4	2/6	2/6
3	5/5	nivolumab + ipilimumab	50 10	4/10	6.1/4.47	7.5/3.2	4/5	3/5

^a Incidence of repeated diarrhea (number of animals with finding/number of animal examined).

^b Mean spleen weight on days 30 and 59; at day 30, 3 monkeys per sex per group with the exception of 2 males in Group 3; at day 59, 2 monkeys per sex per group.

^c Incidence of lymphoid follicle hypertrophy or marginal zone expansion: number of animals with finding (n) / number of animals examined (N).

^d Minimal, diffuse lymphoplasmacytic inflammation in the lamina propria with concurrent enlargement of the colonic or pelvic lymph nodes: number of animals with finding (n) / number of animal examined (N).