. Author manuscript; available in PMC: 2013 Apr 1.

Published in final edited form as: Clin Cancer Res. 2012 Jan 23;18(7):2039–2047. doi: 10.1158/1078-0432.CCR-11-1823

Table 3.

Incidence of grade III/IV immune-related adverse events (IRAEs).

	Protocol 1 Ipi+ gp100	Protocol 2 Ipi + IL-2	Protocol 3 Ipi (DE) ± gp100
	No. of pts. (%) (N = 56)	No. of pts. (%) (N = 36)	No. of pts. (%) (N = 85)
Response status
PR	1 (out of 3 PRs; 33%)	1 (out of 3 PRs; 33%)	7 (out of 12 PRs; 58%)
CR	4 (out of 4 CRs; 100%)	1 (out of 6 CRs; 17%)	3 (out of 5 CRs; 60%)
Any OR	5 (out of 7 ORs; 71%)	2 (out of 9 ORs; 22%)	10 (out of 17 ORs; 59%)
Non-responders	11 (out of 49 NRs; 22%)	4 (out of 27 NRs; 15%)	17 (out of 68 NRs; 25%)
All Patients	16 (29%)	6 (17%)	27 (32%)
Specific Grade III/IV IRAE^*
Gastrointestinal	7	5	17^§
Dermatitis	7	1	2
Hypophysitis	1	0	12
Uveitis	1	1	0^†
Arthritis	0	1	1
Hepatitis	1	0	0
Nephritis	0	0	1
Mucositis	0	1	0

Number of IRAE events > number of patients experiencing IRAEs due to ≥ 1 IRAE per patient.

^§

One patient underwent emergency right colectomy and ileostomy for colonic perforation.

^†

One patient was previously reported (5) to have grade III/IV anterior uveitis in this protocol but on review actually had a grade II event.

Abbreviations: CR, complete response; DE, intra-patient dose escalation of ipilimumab; gp100, gp100:209–217(210M) and gp100:280–288(288V) peptides; IL-2, interleukin-2; ipi, ipilimumab; IRAE, immune-related adverse event; NR, non-responder; OR, objective response; PR, partial response.