Table 4. Drug-related adverse events.
| First author. Year. Ref | Follow up months | All grade | G3-4 | Most common AE | SAEs | IrAEs | Discontinue treatment# |
|---|---|---|---|---|---|---|---|
| Ansell, S. M. 2015 [7] | 10 (0 to 18.75). | 78% | 22% | Rash 22%, thrombocytopenia 17% | Pancreatitis1; MDS1; lymph-node pain 1 | Unclear | MDS and thrombocytopenia 1; And pancreatitis 1 |
| Herrera, A. F. 2016 [8] | Unclear | 78% | 13% | Fatigue 35%, nausea 26%, rash 22%, dyspnea 17%, myalgia17%, and pruritus 17% | (Dehydration, hypercalcemia, and acute kidney injury) 1 | Rash 2; and hypothyroidism 1 | 0 |
| Timmerman, J. M. 2016 [9] | 15.4 (1.9-18.5) | 93% | 29% | Fatigue 11%, infusion reaction 11%, and diarrhea 11% | Pyrexia, pneumonia, tumor progression, arrhythmia, infusion reaction, and meningitis (≤4% each) | Unclear | Unclear |
| Zinzani, P. L. 2016 [10] | 8.8 | 68% | 19% | Pyrexia 13%, diarrhea 11%, cough 8%, fatigue 8%, and neutropenia 8% | Unclear | Unclear | 0 |
| Armand, P. 2016 [11] | 24.9 (7.0-29.7) | 97% | 16% | Hypothyroidism 16%, diarrhea 16%, nausea 13%, and pneumonitis 10% | Colitis 1; increased ALT and AST levels 1; axillary pain 1; back pain and nephrotic syndrome 1; and joint swelling 1 |
Unclear | G2 pneumonitis 1 G3 nephrotic syndrome 1 |
| Diefenbach, C. S. 2016 [12] | 3.6 | 90% | 20% | Transaminitis 29%, peripheral sensory neuropathy19%, and rash 9.6% | 0 | Unclear | (Pneumonitis G3 with G3 dyspnea, hypoxia, and typhilits G3) 1 |
| Lesokhin, A. M. 2016 [13] | 16.65 (0.4-33.0) | 72% | 24% | Skin (pruritus, rash) 18%, fatigue 17%, pneumonitis 11%, and decreased appetite 9% | G5 (fatal pneumonitis/ARDS) 1 | G1 or G2 28 (only 15 required treatment; of these, five had to discontinue nivolumab) | G1 (myositis and conjunctivitis) 1; G2 (enteritis and pneumonitis) 2; G3 (pneumonitis, stomatitis, neutropenia, diplopia, creatine phosphokinase increase, and rash) 6; G4 (pneumonitis, pustular rash, and sepsis) 3 |
| Maruyama, D.2017 [14] | 9.8 (6.0-11.1) | 100% | 23.50% | Pyrexia 41.2%, pruritus 35.3%, rash 35.3%, and hypothyroidism 29.4% | (Pyrexia, hepatic function abnormal, hyponatremia, fulminant type 1 diabetes mellitus, interstitial lung disease and rash) 3 |
Skin disorders 8;Endocrine disorders 6 Gastrointestinal disorders 3 Hepatic disorders 2 Pulmonary disorders 1 Hypersensitivity and infusion reactions 1 |
Interstitial lung disease 1; rash 1; and G2 peripheral neuropathy 1 |
| Nayak, L.2017 [15] | median 17 | 40% | 0% | Unclear | 0 | 0 | 0 |
| Robert Chen. 2017 [16] | 10.1 (1.0-15.0) | Unclear | Unclear | Hypothyroidism 12.4%, pyrexia 10.5% | 0 | Unclear | 9 (Myocarditis, myelitis, myositis, pneumonitis, infusion-related reactions, and cytokine release syndrome) |
| Ding, W.2017 [17] | 10.4 (2.7-16.1) | 100% | 60% | Cough 28%, thrombocytopenia 24%, anemia 20%, nausea 20%, neutropenia 16%, dyspnea 16%, fatigue 12%, diarrhea 12%, and vomiting 12% |
1 G3 lung infections 1 G3 hepatic toxicities 2 G2 pneumonitis 2 Early death |
Unclear | Unclear |
| Zinzani, P. L. 2017 [18] | 14.3 (0.6-34.7) | 67% | 23.8% | Unclear | 7 | Unclear | 0 |
| Timmerman, J. M.2017 [19] | 14 (1-20) | 75% | 11% | Fatigue 29% and diarrhea 21% | Unclear | Unclear | Unclear |
SAE: Drug-related serious adverse events; IrAEs: immune-related adverse events; MDS: myelodysplastic syndrome; and discontinued treatment: patients had toxic effects.