Table 2.
ICI-induced irADRs reported from January 1, 2002, and February 28. 2019 and collected into the RNF (data available from the RAM system).
| TOXICITY TYPE |
Tot. irADRs n (%) |
ICIs | |||||
|---|---|---|---|---|---|---|---|
| Nivolumab n (%) |
Pembrolizumab n (%) |
Atezolizumab n (%) |
Ipilimumab n (%) |
Avelumab n (%) |
Durvalumab n (%) |
||
| Gastrointestinal Toxicity | 264 (33) | 132 (50) | 22 (8) | 2 (1) | 108 (41) | - | - |
| Diarrhea | 225 | 115 | 11 | 2 | 97 | – | – |
| Pancreatitis | 20 | 12 | 6 | – | 2 | – | – |
| Enterocolitis | 12 | 5 | 5 | – | 2 | – | – |
| Celiac Disease | 3 | – | – | – | 3 | – | – |
| Gastritis | 2 | – | – | – | 2 | – | – |
| Ileitis | 2 | – | – | – | 2 | – | – |
| Skin Toxicity | 139 (17) | 103 (74) | 22 (16) | 8 (6) | 6 (4) | - | - |
| Itch | 94 | 71 | 16 | 6 | 1 | – | – |
| Psoriasis | 20 | 15 | 2 | 2 | 1 | – | – |
| MP Rash | 13 | 10 | 2 | – | 1 | – | – |
| SJS | 8 | 4 | 2 | – | 2 | – | – |
| Vitiligo | 4 | 3 | – | – | 1 | – | – |
| Pulmonary Toxicity | 129 (16) | 59 (46) | 11 (8) | 1 (1) | 57 (44) | - | 1 (1) |
| Pneumonia | 87 | 59 | 11 | 1 | 15 | – | 1 |
| Pleurisy | 42 | – | – | – | 42 | – | – |
| Hematological Toxicity | 98 (12) | 81 (83) | 8 (8) | 9 (9) | – | – | – |
| Hemolytic Anemia | 41 | 37 | – | 4 | – | – | – |
| Thrombocytopenia | 37 | 31 | 2 | 4 | – | – | – |
| Neutropenia | 20 | 13 | 6 | 1 | – | – | – |
| Endocrine Toxicity | 91 (11) | 52 (57) | 17 (19) | 1 (1) | 21 (23) | - | - |
| Hyperthyroidism | 36 | 32 | – | 1 | 3 | – | – |
| Hypothyroidism | 18 | 5 | 10 | – | 3 | – | – |
| Hypophysitis | 16 | 7 | 5 | – | 4 | – | – |
| Adrenal insufficiency | 16 | 7 | 2 | – | 7 | – | – |
| Diabetes | 5 | 1 | – | – | 4 | – | – |
| Liver Toxicity | 22 (2.7) | 11 (50) | 10 (45) | 1 (5) | - | - | - |
| Hepatitis | 22 | 11 | 10 | 1 | – | – | – |
| Musculoskeletal Toxicity | 19 (2.4) | 14 (74) | 4 (21) | 1 (5) | - | - | - |
| Arthritis | 11 | 9 | 1 | 1 | – | – | – |
| Myositis | 7 | 5 | 2 | – | – | – | – |
| Myopathies | 1 | – | 1 | – | – | – | – |
| Central Toxicity | 16 (2) | 8 (50) | 7 (44) | - | - | 1 (6) | - |
| Neuropathy | 7 | 4 | 3 | – | – | – | – |
| Encephalitis | 6 | 4 | 2 | – | – | – | – |
| GBS | 2 | – | 2 | – | – | – | – |
| Myasthenia | 1 | – | – | – | – | 1 | – |
| Ocular Toxicity | 9 (1.1) | 8 (89) | 1 (11) | - | - | - | - |
| Conjunctivitis | 6 | 6 | – | – | – | – | – |
| Uveitis | 3 | 2 | 1 | – | – | – | – |
| Renal Toxicity | 7 (0.9) | 5 (71) | 2 (29) | - | - | - | - |
| Nephritis | 7 | 5 | 2 | – | – | – | – |
| Cardiovascular Toxicity | 7 (0.9) | 5 (71) | 2 (29) | - | - | - | - |
| Myocarditis | 4 | 3 | 1 | – | – | – | – |
| Pericarditis | 2 | 1 | 1 | – | – | – | – |
| Vasculitis | 1 | 1 | – | – | – | – | – |
MP rash, maculo-papular rash; SJS, Steven Johnson’s syndrome; GBS, Guillain-Barré syndrome.