Reported incidence of irAEs in published ICI clinical trials for metastatic TNBC (adapted from D’Abreo and Adams, Nat Rev Clin Oncol, 2019214)
| irAE | All grades (%) | Grade 3–4 (%) | Grade 5 (%) | |
| Dermatologic | Pruritus, rash | 18 | 0.5 | 0 |
| Endocrine | Hypothyroidism | 12 | 0 | 0 |
| Hyperthyroidism | 5 | 0.1 | 0 | |
| Gastro-intestinal | Hepatitis, elevated transaminases | 10 | 3 | 0.2 |
| Colitis, diarrhea | 2.5 | 0.45 | 0 | |
| Hematologic | Prespecified autoimmune anemia, lymphopenia, thrombocytopenia and clotting abnormalities | 4 | 1 | 0.2 |
| Respiratory | Pneumonitis | 3 | 0.5 | 0.1 |
| Other (<1%) | Adrenal insufficiency, type 1 diabetes, ocular, myocarditis, neurological/meningitis, nephritis/elevated creatinine | <1 | <0.5 | 0 |
ICI, immune checkpoint inhibitor; irAEs, immune-related adverse events; TNBC, triple-negative breast cancer.