Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study

Table 3 Summary of adverse events using CTCAE criteria

	All IPI-treated patients^a
	On study^b (n = 1151)	Early onset^c (n = 1151)	Late onset^d (n = 653)
Any treatment-related adverse event, no. (%)
Any grade	756 (66)	734 (64)	128 (20)
Grade ≥ 3	296 (26)	275 (24)	42 (6)
Serious adverse event	225 (20)	218 (19)	15 (2)
Immune-related adverse event, no. (%)
Any grade	569 (49)	550 (48)	65 (10)
Grade ≥ 3	211 (19)	211 (18)	20 (3)
Treatment-related adverse event/serious adverse event leading to discontinuation, no. (%)
Any grade	158 (14)	148 (13)	14 (2)
Grade ≥ 3	102 (9)	99 (9)	4 (1)
Treatment-related adverse event/serious adverse event leading to death,^e no. (%)
Any grade	22 (2)	21 (2)	1 (<1)
Grade ≥ 3	17 (1)	16 (1)	1 (<1)

CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events, IPI, ipilimumab.
^aIncludes patients who received ipilimumab therapy at any time during the study period (IPI-noOther, IPI-Other, Other-IPI)
^bFrom first dose of ipilimumab until discontinuation from study or end of study, whichever came first
^cOccurring between the first dose and 90 days after the last dose of ipilimumab therapy
^dOccurring 90 days after the last dose of ipilimumab; the denominator is the number of ipilimumab-treated patients who were in the post-treatment phase of follow-up
^e10 deaths were attributed to immune-related adverse events

ISSN: 1471-2407