Table 2. Description of Immune-Related Adverse Events.
| Type of adverse event | Immune-related adverse events, No./total No. (%) | Details | |
|---|---|---|---|
| Per type | Per patient | ||
| Associated with ipilimumab therapy | |||
| Gastrointestinal | 35/75 (47) | 35/56 (63) | Colitis (n = 34), pancreatitis (n = 1) |
| Endocrine | 17/75 (23) | 17/56 (30) | Hypophysitis (n = 15), dysthyroidism (n = 2) |
| Cutaneous | 3/75 (4) | 3/56 (5) | Rashes (n = 3) |
| Hematologic | 5/75 (7) | 5/56 (9) | Immune thrombocytopenia (n = 1), macrophagic activation syndrome (n = 1), hypereosinophilia (n = 3) |
| Hepatobiliary | 5/75 (7) | 5/56 (9) | Cholestasis (n = 1), hepatitis (n = 4) |
| Renal | 4/75 (5) | 4/56 (7) | Acute renal failure, nephritis (n = 4) |
| Neurologic | 2/75 (3) | 2/56 (4) | Lymphocytic meningitis (n = 1), Guillain-Barré syndrome (n = 1) |
| Ocular | 1/75 (1) | 1/56 (2) | Uveitis (n = 1) |
| Rheumatologic | 1/75 (1) | 1/56 (2) | Arthritis (n = 1) |
| Associated with anti–programmed cell death 1 therapy | |||
| Endocrine | 6/23 (26) | 6/56 (11) | Imbalances from diabetes (n = 2),a dysthyroidism (n = 1), hypoadrenalism (n = 1), hyperosmolar coma (n = 1),a hypophysitis (n = 1)a |
| Pulmonary | 5/23 (22) | 5/56 (9) | Pneumonitis (n = 4),a sarcoidosis (n = 1)a |
| Cutaneous | 4/23 (17) | 4/56 (7) | Vitiligo (n = 3), pruritus (n = 1)a |
| Gastrointestinal | 4/23 (17) | 4/56 (7) | Colitis (n = 4)a |
| Hepatobiliary | 1/23 (4) | 1/56 (2) | Hepatitis (n = 1) |
| Neurologic | 1/23 (4) | 1/56 (2) | Lymphocytic meningitis (n = 1)a |
| Hematologic | 1/23 (4) | 1/56 (2) | Immune pancytopenia (n = 1)a |
a
At least 1 grade 3 or 4 immune-related adverse event. Interruptions of anti–programmed cell death 1 treatment course (n = 5) were attributable to pneumonitis (n = 1), pruritus (n = 1), lymphocytic meningitis (n = 1), hyperosmolar coma and colitis (n = 1), and hepatitis (n = 1).