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. 2018 Sep 13;4(12):1721–1728. doi: 10.1001/jamaoncol.2018.3923

Table 1. Spectrum of Fatal Immune-Related Adverse Events in Vigilyze.

Variable No. (%) P Value
Ipilimumab (n = 193) Anti–PD-1/PD-L1 (n = 333) Combination (n = 87)
Types of cancera <.001
Melanoma 136 (96) 50 (18) 49 (66)
Lung cancer 0 152 (54) 17 (23)
Other 5 (4) 78 (28) 8 (11)
Type of fatal irAE
Colitis 135 (70) 58 (17) 32 (37) <.001
Pneumonitis 15 (8) 115 (35) 12 (14) <.001
Hepatitis 31 (16) 74 (22) 19 (22) .23
Hypophysitis 10 (5) 3 (1) 2 (2) .01
Cardiac 3 (2) 27 (8) 22 (25) <.001
Myositis 1 (0.5) 22 (7) 11 (13) <.001
Nephritis 1 (0.5) 7 (2) 3 (4) .19
Adrenal 8 (4) 6 (2) 3 (4) .26
Neurologic 11 (6) 50 (15) 7 (8) .003
Hematologic 3 (2) 14 (4) 2 (2) .22
Other (skin, thyroid, diabetes, other gastrointestinal) 13 (7) 24 (8) 7 (8) .93
Other clinical features
Median time to irAE, days 40 40 14 .01
>1 concurrent irAE, % 27 (14) 51 (15) 24 (28) .01
Reporting year
2014 or before 98 (51) 3 (1) 2 (2) <.001
2015 45 (23) 20 (6) 9 (10) <.001
2016 21 (11) 88 (28) 17 (20) .001
2017 26 (13) 192 (58) 44 (51) <.001
2018 (up to January 15) 3 (2) 30 (9) 15 (17) <.001

Abbreviations: irAE, immune-related adverse event; PD-L1, programmed death ligand-1; PD-1, programmed death-1.

a

Percent of known (52 patients treated with ipilimumab, 53 with anti–PD-1/PD-L1, and 13 with combination did not list cancer types).