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Table 3 Specific causes for nivolumab-related SAE (serious adverse event) and FAE (fatal adverse event)

From: Serious adverse events and fatal adverse events associated with nivolumab treatment in cancer patients

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)
  1. Abbreviation: ALT alanine aminotransferase; AST aspartate aminotransferase; CC colorectal cancer; G/GJC gastric or gastro-esophageal junction cancer; HL, Hodgkin lymphoma; HNC head and neck cancer; LC lung cancer; M melanoma; OC ovarian cancer; S sarcoma