Table 2.

Treatment Related Toxicities. Table 2a shows the overall safety summary and Table 2b summarizes selected immune related adverse events.Table 2a. Safety summary by study arm (n=83). Table 2b.Selected Immune-Related Adverse Events (%)

	Ipi10 + HDI (n = 18)		Ipi10 (n = 22)		Ipi3 + HDI (n = 21)		Ipi3 (n = 22)
	Any Grade	Grade 3/4/5	Any grade	Grade 3/4/5	Any Grade	Grade 3/4/5	Any Grade	Grade 3/4/5
Any AE, %	100	94	100	63	100	76	100	46
Any immune-related AE, %	100	39	77	36	76	33	86.4	32
Grade 5 events that were considered at least possibly related (n=3): • Suicide (Ipi10 + HDI) • Lung infection and haemorrhage (Ipi10) • Adult respiratory distress syndrome (Ipi3 + HDI) • An additional patient died of gastrointestinal bleed and cardiac arrest while on corticosteroids to treat temporal arteritis and vision loss (Ipi10)

	Ipi10 + HDI (n = 18)			Ipi10 (n = 22)			Ipi3 + HDI (n = 21)			Ipi3 (n = 22)
	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4
Dermatologic
Rash	83	11	-	64	5	-	29	5	-	50	5	-
Gastrointestinal
Diarrhea	61	0	0	27	9	0	33	5	-	36	5	-
Colitis	6	-	-	-	-	-	5	-	-	-	-	-
Pancreas
Lipase increase	39	-	6	9	9	-	14	-	-	9	5	5
Endocrine
Hypophysitis	6	6	-	-	-	-	-	-	-	5	-	5
Adrenal insuff.	6	6	-	14	-	-	5	-	-	5	-	-
Hypothyroid	28	-	-	9	-	-	10	-	-	14	-	-
Hepatic
ALT/AST increase	67	17	-	9	9	-	57	19	-	9	-	5
Neurologic
Peripheral sensory neuropathy	6	-	-	5	-	-	5	-	-	-	-	-
Other
CPK increase	11	-	11	-	-	-	10	5	-	-	-	-

Arm A (ipilimumab 10 mg/kg [ipi10] + high-dose interferon-α [HDI])

Arm B (ipilimumab 10 mg/kg alone)

Arm C (ipilimumab 3 mg/kg [ipi3] + high-dose interferon-α)

Arm D (ipilimumab 3 mg/kg alone)

IFN: Interferon; peg-IFN: Pegylated-interferon