Table 5.

Summary of change from baseline in HRQoL score at Week 10 by Treatment and AE Status at week 10 visit.

	Placebo		Ipilimumab
	AE absent	AE present	AE absent	AE present
Diarrhea
Mean (SD)	−1.34 (14.66)	14.35 (30.98)	5.21 (20.40)	23.08 (39.34)
N obs	324	79	224	130
Appetite loss
Mean (SD)	1.66 (14.63)	22.22 (27.22)	7.84 (23.35)	18.33 (33.29)
N obs	401	6	336	20
Fatigue
Mean (SD)	1.83 (17.09)	11.39 (20.34)	8.65 (22.40)	16.62 (27.25)
N obs	309	98	239	119
Insomnia
Mean (SD)	−3.35 (24.01)	14.81 (55.56)	7.43 (27.48)	4.17 (36.26)
N obs	398	9	341	16
Nausea/vomiting
Mean (SD)	0.42 (6.68)	15.41 (21.40)	3.88 (14.10)	20.45 (27.70)
N obs	354	53	292	66