Table 3.
Immune-related adverse events ipilimumab. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.02. No grade 4 adverse events were reported. One death was determined by the investigators to be related to ipilimumab (inflammatory colitis with bowel perforation).
Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 5 | |
---|---|---|---|---|---|
Any immune-related adverse event | 28 (58.3%) | 17 (35.4%) | 4 (8.3%) | 9 (18.8%) | 1 (2.1%) |
Dermatitis | 14 (29.2%) | 13 (27.1%) | 0 | 1 (2.1%) | 0 |
Diarrhea/colitis | 13 (27.1%) | 5 (10.4%) | 2 (4.2%) | 5 (10.4%) | 1 (2.1%) |
Uveitis | 3 (6.3%) | 0 | 1 (2.1%) | 2 (4.2%) | 0 |
Conjunctivitis | 2 (4.2%) | 2 (4.2%) | 0 | 0 | 0 |
Hypophysitis | 1 (2.1%) | 0 | 0 | 1 (2.1%) | 0 |
Pneumonitis | 1 (2.1%) | 0 | 1 (2.1%) | 0 | 0 |
Vitiligo | 1 (2.1%) | 1 (2.1%) | 0 | 0 | 0 |
Treatment-related adverse event leading to discontinuation | 5 (10.4%) | 0 | 1 (2.1%) | 3 (6.3%) | 1 (2.1%) |