Table 3 Specific causes for nivolumab-related SAE (serious adverse event) and FAE (fatal adverse event)
Nivolumab-related AE | SAE (n = 196) | Disease type (n) | FAE(n = 13) |
|---|---|---|---|
Respiratory events | 42(21.4%) | LC (30), G/GJC (9), HL (1), M (1), S (1) | 5(38.5%) |
Pneumonitis | 16 | LC (14), G/GJC (2) | LC (2), G/GJC (1), HNC (1) |
Interstitial lung disease | 11 | LC (6), G/GJC (4), HL (1) | 0 |
Pleural effusion | 4 | LC (2), M (1), S (1) | 0 |
Dyspnea | 2 | LC (1), G/GJC (1) | G/GJC (1) |
Lung disorder | 2 | LC (2) | 0 |
Lung infection | 2 | G/GJC (2) | 0 |
Bronchitis | 1 | LC (1) | 0 |
Chronic obstructive pulmonary disease | 1 | LC (1) | 0 |
Hypoxia | 1 | LC (1) | 0 |
Respiratory tract infection | 1 | LC (1) | 0 |
Pulmonary embolism | 1 | LC (1) | 0 |
Gastrointestinal events | 15(7.7%) | LC (7), CC (3), G/GJC (2), S (2), M (1) | 0(0.0%) |
Colitis | 7 | LC (3), G/GJC (2), CC (1), M (1) | 0 |
Diarrhea | 3 | CC (1), LC (1), S (1) | 0 |
Nausea | 2 | LC (2) | 0 |
Decreased appetite | 1 | LC (1) | 0 |
Anorexia | 1 | S (1) | 0 |
Gastritis | 1 | CC (1) | 0 |
Hepatic events | 13(6.6%) | LC (9), G/GJC (1), CC (1), HL (1), M (1) | 1(7.7%) |
AST increased | 6 | LC (6) | 0 |
Hepatotoxicity | 5 | LC (2), M (1), G/GJC (1), HL (1) | 0 |
ALT increased | 1 | CC (1) | 0 |
Transaminases increased | 1 | LC (1) | 0 |
Hepatitis | 0 | NA | G/GJC (1) |
Renal and urinary events | 9(4.6%) | LC (3), G/GJC (3), CC (1), HL (1), M (1) | 0(0.0%) |
Blood creatinine increased | 2 | LC (2) | 0 |
Hyponatremia | 2 | G/GJC (1), HL (1) | 0 |
Acute kidney injury | 1 | CC (1) | 0 |
Renal impairment | 1 | M (1) | 0 |
Tubulointerstitial nephritis | 1 | LC (1) | 0 |
Urinary tract infection | 2 | G/GJC (2) | 0 |
Cardiovascular events | 6(3.1%) | LC (5), OC (1) | 2(15.4%) |
Cerebrovascular accident | 2 | LC (2) | 0 |
Atrial fibrillation | 1 | LC (1) | 0 |
Cardiac tamponade | 1 | LC (1) | 0 |
Deep vein thrombosis | 1 | OC (1) | 0 |
Pericardial effusion | 1 | LC (1) | 0 |
Cardiac arrest | 0 | NA | G/GJC (1) |
Ischemic stroke | 0 | NA | LC (1) |
Nervous system events | 6(3.1%) | M (2), LC (2), OC (2) | 1(7.7%) |
Encephalitis | 1 | LC (1) | LC (1) |
Headache | 2 | M (2) | 0 |
Disorientation | 1 | OC (1) | 0 |
Dizziness | 1 | LC (1) | 0 |
Gait disorder | 1 | OC (1) | 0 |
Endocrine events | 6(3.1%) | LC (2), G/GJC (2), CC (1), HL (1) | 0(0.0%) |
Adrenal insufficiency | 2 | LC (1), CC (1) | 0 |
Diabetic ketoacidosis | 2 | G/GJC (2) | 0 |
Diabetes mellitus | 1 | HL (1) | 0 |
Hypothyroidism | 1 | LC (1) | 0 |
Musculoskeletal events | 5(2.6%) | LC (3), CC (2) | 0(0.0%) |
Arthritis | 1 | CC (1) | 0 |
Myasthenic syndrome | 1 | LC (1) | 0 |
Osteonecrosis | 1 | LC (1) | 0 |
Polymyalgia rheumatica | 1 | LC (1) | 0 |
Pain | 1 | CC (1) | 0 |
Blood events | 2(1.0%) | S (2) | 1(7.7%) |
Anemia | 1 | S (1) | 0 |
Decreased platelet count | 1 | S (1) | 0 |
Neutropenia | 0 | NA | M (1) |
Skin and subcutaneous tissue events | 1(0.5%) | HL (1) | 0(0.0%) |
Rash | 1 | HL (1) | 0 |
Other | 20(10.2%) | LC (6), G/GJC (5), HL (3), OC (2), S(2), M (1), CC (1) | 3(23.1%) |
Pyrexia | 5 | LC (2), G/GJC (2), HL (1) | 0 |
Infusion related reaction | 4 | LC (2), HL (2) | 0 |
Fever | 3 | OC (2), S (1) | 0 |
Dehydration | 3 | G/GJC (2), S (1) | 0 |
Chills | 1 | LC (1) | 0 |
Fatigue | 1 | G/GJC (1) | 0 |
Radio-necrosis | 1 | M (1) | 0 |
Stomatitis | 1 | CC (1) | 0 |
Subdural hematoma | 1 | LC (1) | 0 |
Multiorgan failure | 0 | NA | LC (1) |
Hypercalcemia | 0 | NA | HNC (1) |
Unknown reason | 0 | NA | G/GJC (1) |