Table 2. Adverse Events in Safety Population at the Interim Analysis.
| Sintilimab plus chemotherapy (n = 328) | Placebo plus chemotherapy (n = 320) | |||
|---|---|---|---|---|
| ≥Grade 3 | All grades | ≥Grade 3 | All grades | |
| Any treatment-related adverse eventsa | 196 (59.8) | 319 (97.3) | 168 (52.5) | 308 (96.3) |
| Treatment-related adverse events in 15% or more of treated patients in either groupb | ||||
| Platelet count decreased | 81 (24.7) | 217 (66.2) | 68 (21.3) | 209 (65.3) |
| Neutrophil count decreased | 66 (20.1) | 195 (59.5) | 60 (18.8) | 177 (55.3) |
| White blood cell count decreased | 25 (7.6) | 176 (53.7) | 22 (6.9) | 172 (53.8) |
| Anemia | 41 (12.5) | 153 (46.6) | 28 (8.8) | 148 (46.3) |
| Nausea | 11 (3.4) | 138 (42.1) | 3 (0.9) | 120 (37.5) |
| Vomiting | 12 (3.7) | 131 (39.9) | 6 (1.9) | 127 (39.7) |
| Elevated aspartate aminotransferase | 4 (1.2) | 108 (32.9) | 1 (0.3) | 99 (30.9) |
| Elevated alanine aminotransferase increased | 2 (0.6) | 71 (21.6) | 1 (0.3) | 61 (19.1) |
| Decreased appetite | 2 (0.6) | 69 (21.0) | 1 (0.3) | 63 (19.7) |
| Hypothyroidism | 0 | 58 (17.7) | 0 | 30 (9.4) |
| Hyperbilirubinemia | 8 (2.4) | 56 (17.1) | 4 (1.3) | 60 (18.8) |
| Palmar-plantar erythrodysesthesia syndrome | 11 (3.4) | 56 (17.1) | 12 (3.8) | 51 (15.9) |
| Asthenia | 5 (1.5) | 52 (15.9) | 4 (1.3) | 48 (15.0) |
| Hypoesthesia | 2 (0.6) | 50 (15.2) | 2 (0.6) | 36 (11.3) |
| Any immune-related adverse events | 35 (10.7) | 114 (34.8) | 11 (3.4) | 68 (21.3) |
| Immune-related adverse events in 2% or more of patients in either groupc | ||||
| Hypothyroidism | 0 | 45 (13.7) | 0 | 21 (6.6) |
| Hyperthyroidism | 0 | 20 (6.1) | 0 | 6 (1.9) |
| Amylase increased | 1 (0.3) | 17 (5.2) | 2 (0.6) | 9 (2.8) |
| Rash | 0 | 16 (4.9) | 0 | 3 (0.9) |
| Aspartate aminotransferase increased | 0 | 11 (3.4) | 0 | 6 (1.9) |
| Blood thyroid stimulating hormone increased | 0 | 9 (2.7) | 0 | 6 (1.9) |
| Lipase increased | 4 (1.2) | 9 (2.7) | 1 (0.3) | 4 (1.3) |
| Platelet count decreased | 4 (1.2) | 7 (2.1) | 2 (0.6) | 4 (1.3) |
a
Adverse events were classified according to Medical Dictionary for Regulatory Activities and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (range, 1-5 [1, mild; 2, moderate; 3, severe; 4, life-threatening; and 5, death]).
b
Treatment-related adverse events to any drug occurring in 15% or more of patients in either group are shown in descending order of frequency in the sintilimab plus chemotherapy group.
c
Immune-related adverse events (related to sintilimab with potential immunologic etiology) assessed by investigators occurring in 2% or more of patients in either group are listed in descending order.