| Immune-related adverse reactions | Severity | Treatment adjustment |
| reactive capillary hyperplasia | Grade 3 | Drug suspension |
| Permanent discontinuation | ||
| Pneumonia | Grade 2 | Suspension of dosing until adverse reactions return to grade 0 to 1 |
| Permanent discontinuation | ||
| Diarrhea and colitis | Grade 2 or 3 | Suspension of dosing until adverse reactions return to grade 0 to 1 |
| Permanent discontinuation | ||
| Hepatitis | Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at 3 to 5 times the upper limit of normal (ULN) or total bilirubin (TBIL) at 1.5 to 3 times the ULN | Suspend dosing until adverse reactions return to grade 0 to 1 |
| Permanent discontinuation of medication | ||
| Grade 2 to 3 elevated blood creatinine | Suspension of dosing until adverse reactions return to grade 0 to 1 | |
| Grade 4 blood creatinine elevation | Permanent discontinuation | |
| Endocrine disease | Symptomatic grade 2 to 3 hypothyroidism, grade 2 to 3 hyperthyroidism, grade 2 to 3 pituitary gland inflammation, grade 2 adrenal insufficiency Grade 3 hyperglycemia or type 1 diabetes mellitus |
Suspend dosing until adverse reactions return to grade 0 to 1 |
| Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 pituitary gland inflammation Grade 3 to 4 adrenal insufficiency Grade 4 hyperglycemia or type 1 diabetes mellitus |
Permanent discontinuation of medication | |
| Grade 3 | Suspension of dosing until adverse reactions return to grade 0 to 1 | |
| Permanent discontinuation of medication | ||
| Thrombocytopenia | Grade 3 | Suspension of dosing until adverse reactions return to grade 0 to 1 |
| Permanent discontinuation | ||
| Other immune-related adverse reactions | Grade 3 to 4 elevated blood amylase or elevated lipase Grade 2 to 3 pancreatitis Grade 2 myocarditis Grade 2 to 3 first occurrence of other immune-related adverse reactions |
Suspension of dosing until adverse reactions return to grade 0 to 1 |
| Grade 4 pancreatitis or recurrent pancreatitis of any grade Grade 3 to 4 myocarditis Grade 3 to 4 encephalitis Grade 4 first occurrence of other immune-related adverse reactions |
Permanent discontinuation | |
| Recurrence or persistent adverse reactions | Recurrence grade 3 to 4 (except endocrine disease) Grade 2 to 3 adverse reactions within 12 weeks of last dose Not improved to grade 0 to 1 (except endocrine disease) Failure to reduce glucocorticoids to a prednisone equivalent dose of ≤10 mg/d within 12 weeks of final dosing |
Permanent discontinuation |
| Grade 2 | Reduce titration rate or suspend dosing, consider resuming when symptoms resolve and observe closely | |
| Permanent discontinuation of medication |