Table 1. Incidence proportion and incidence rate of irAEs in patients treated with atezolizumab (alone or in combination) and chemotherapy.
irAE | IO/C-IO(N=6,229) | Chemotherapy(N=3,292) | ||
irAEn (%) | irAE per100 patient-years | irAEn (%) | irAE per100 patient-years | |
Any irAE | 2707 (43.5) | 86.86 | 823 (25) | 66.84 |
Skin | 1476 (23.7) | 36.37 | 475 (14.4) | 34.57 |
Hepatitis | 839 (13.5) | 17.16 | 296 (9) | 19.66 |
Thyroid | 767 (12.3) | 16.14 | 91 (2.8) | 5.79 |
Pneumonitis | 256 (4.1) | 4.77 | 36 (1.1) | 2.23 |
Colitis | 93 (1.5) | 1.7 | 9 (0.3) | 0.56 |
Adrenal insufficiency | 53 (0.9) | 0.97 | 6 (0.2) | 0.37 |
Pancreatitis | 52 (0.8) | 0.95 | 6 (0.2) | 0.37 |
Diabetes mellitus | 35 (0.6) | 0.64 | 11 (0.3) | 0.68 |
Myositis myositis+rhabdomyolysis | 30 (0.5) | 0.55 | 4 (0.1) | 0.25 |
Meningoencephalitis | 29 (0.5) | 0.53 | 4 (0.1) | 0.25 |
Meningitis | 23 (0.4) | 0.42 | 4 (0.1) | 0.25 |
Nephritis | 20 (0.3) | 0.36 | 3 (0.1) | 0.18 |
Ocular inflammatory toxicity | 20 (0.3) | 0.36 | 1 (0) | 0.06 |
Vasculitis | 17 (0.3) | 0.31 | 3 (0.1) | 0.18 |
Hypophysitis | 12 (0.2) | 0.22 | 0 (0) | 0 |
Systemic immune activation | 8 (0.1) | 0.15 | 0 (0) | 0 |
Autoimmune hemolytic anemia | 7 (0.1) | 0.13 | 1 (0) | 0.06 |
Guillain-Barre syndrome | 6 (0.1) | 0.11 | 0 (0) | 0 |
Encephalitis | 6 (0.1) | 0.11 | 0 (0) | 0 |
Myocarditis | 4 (0.1) | 0.07 | 1 (0) | 0.06 |
Myasthenia gravis | 0 (0) | 0 | 1 (0) | 0.06 |
Any irAE=any of the other immune-related AEs in the table.
Skin=immune-related rash, immune-related severe cutaneous reactions.
Hepatitis=immune-related hepatitis (clinical diagnosis), immune-related hepatitis (laboratory abnormalities).
Thyroid=immune-related hypothyroidism, immune-related hyperthyroidism, immune-related thyroiditis.
irAEs=immune-related adverse events were reported in all study arms, including standard of care without atezolizumab, given the blinded nature of the controlled trials.
irAE n (%) = number and percentage of listed irAE
C-IO, atezolizumab in combination with chemotherapy or bevacizumabIO, atezolizumab monotherapy; irAEimmune-related adverse event