Table 3 Summary of treatment-related adverse events.
Sintilimab (N = 94) | Chemo (N = 87) | |||||
|---|---|---|---|---|---|---|
Any | Grade 1–2 | Grade ≥3 | Any | Grade 1–2 | Grade ≥3 | |
All events | 88 (93.6) | 36 (38.3) | 52 (55.3) | 81 (93.1) | 40 (46.0) | 41 (47.1) |
TRAEs | 51 (54.3) | 32 (34.0) | 19 (20.2) | 79 (90.8) | 45 (51.7) | 34 (39.1) |
Hypothyroidism | 12 (12.8) | 12 (12.8) | 0 | 1 (1.1) | 1 (1.1) | 0 |
Pulmonary inflammation | 10 (10.6) | 5 (5.3) | 5 (5.3) | 1 (1.1) | 1 (1.1) | 0 |
Anemia | 8 (8.5) | 8 (8.5) | 0 | 33 (37.9) | 28 (32.2) | 5 (5.7) |
WBC count decreased | 8 (8.5) | 7 (7.4) | 1 (1.1) | 42 (48.3) | 28 (32.2) | 14 (16.1) |
ALT increased | 7 (7.4) | 7 (7.4) | 0 | 6 (6.9) | 6 (6.9) | 0 |
AST increased | 7 (7.4) | 7 (7.4) | 0 | 5 (5.7) | 5 (5.7) | 0 |
Amylase increased | 6 (6.4) | 4 (4.3) | 2 (2.1) | 0 | 0 | 0 |
Cough | 6 (6.4) | 4 (4.3) | 2 (2.1) | 1 (1.1) | 1 (1.1) | 0 |
Abnormal liver function | 6 (6.4) | 5 (5.3) | 1 (1.1) | 4 (4.6) | 3 (3.4) | 1 (1.1) |
Neutrophils count decreased | 5 (5.3) | 3 (3.2) | 2 (2.1) | 30 (34.5) | 14 (16.1) | 16 (18.4) |
Platelet count decreased | 5 (5.3) | 3 (3.2) | 2 (2.1) | 10 (11.5) | 9 (10.3) | 1 (1.1) |
Fatigue | 5 (5.3) | 5 (5.3) | 0 | 19 (21.8) | 19 (21.8) | 0 |
Lipase elevated | 4 (4.3) | 0 | 4 (4.3) | 0 | 0 | 0 |
Diarrhea | 4 (4.3) | 4 (4.3) | 0 | 29 (33.3) | 24 (27.6) | 5 (5.7) |
Lymphocyte count decreased | 3 (3.2) | 1 (1.1) | 2 (2.1) | 5 (5.7) | 4 (4.6) | 1 (1.1) |
Hypochloremia | 3 (3.2) | 1 (1.1) | 2 (2.1) | 0 | 0 | 0 |
Nausea | 3 (3.2) | 3 (3.2) | 0 | 28 (32.2) | 26 (29.9) | 2 (2.3) |
Proteinuria | 3 (3.2) | 3 (3.2) | 0 | 5 (5.7) | 4 (4.6) | 1 (1.1) |
Vomiting | 2 (2.1) | 2 (2.1) | 0 | 18 (20.7) | 14 (16.1) | 4 (4.6) |
Upper gastrointestinal hemorrhage | 2 (2.1) | 0 | 2 (2.1) | 0 | 0 | 0 |
Lung infection | 2 (2.1) | 0 | 2 (2.1) | 2 (2.3) | 1 (1.1) | 1 (1.1) |
Decreased appetite | 1 (1.1) | 1 (1.1) | 0 | 17 (19.5) | 15 (17.2) | 2 (2.3) |
Abdominal pain | 1 (1.1) | 1 (1.1) | 0 | 6 (6.9) | 6 (6.9) | 0 |
Hypokalemia | 1 (1.1) | 1 (1.1) | 0 | 5 (5.7) | 4 (4.6) | 1 (1.1) |
Alopecia | 0 | 0 | 0 | 13 (14.9) | 13 (14.9) | 0 |
Bone marrow failure | 0 | 0 | 0 | 10 (11.5) | 4 (4.6) | 6 (6.9) |
Hypaesthesia | 0 | 0 | 0 | 6 (6.9) | 4 (4.6) | 2 (2.3) |
Immune-related AE | 29 (30.9) | 21 (22.3) | 8 (8.5) | 0 | 0 | 0 |
Pulmonary inflammation | 9 (9.6) | 5 (5.3) | 4 (4.3) | 0 | 0 | 0 |
Hypothyroidism | 8 (8.5) | 8 (8.5) | 0 | 0 | 0 | 0 |
Rash | 4 (4.3) | 3 (3.2) | 1 (1.1) | 0 | 0 | 0 |
Abnormal liver function | 3 (3.2) | 3 (3.2) | 0 | 0 | 0 | 0 |
Lung infection | 2 (2.1) | 1 (1.1) | 1 (1.1) | 0 | 0 | 0 |
Psoriasis | 2 (2.1) | 2 (2.1) | 0 | 0 | 0 | 0 |
Diarrhea | 2 (2.1) | 2 (2.1) | 0 | 0 | 0 | 0 |
Anemia | 2 (2.1) | 2 (2.1) | 0 | 0 | 0 | 0 |
