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Table 3 Summary of adverse events using CTCAE criteria

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

  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)
  1. CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events, IPI, ipilimumab.
  2. aIncludes patients who received ipilimumab therapy at any time during the study period (IPI-noOther, IPI-Other, Other-IPI)
  3. bFrom first dose of ipilimumab until discontinuation from study or end of study, whichever came first
  4. cOccurring between the first dose and 90 days after the last dose of ipilimumab therapy
  5. 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
  6. e10 deaths were attributed to immune-related adverse events