Table 3.
Summary of adverse events using CTCAE criteria
| All IPI-treated patientsa | |||
|---|---|---|---|
| On studyb (n = 1151) | Early onsetc (n = 1151) | Late onsetd (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