Table 3. Treatment-Related Adverse Events in the Adverse Event Seta.
| Patients who experienced treatment-related adverse events, No. (%)b | ||||
|---|---|---|---|---|
| Any gradec | Grade ≥3d | |||
| Serplulimab (n = 389) | Placebo (n = 196) | Serplulimab (n = 389) | Placebo (n = 196) | |
| Any treatment-related adverse eventa | 272 (69.9) | 110 (56.1) | 129 (33.2) | 54 (27.6) |
| Anemia | 84 (21.6) | 36 (18.4) | 21 (5.4) | 11 (5.6) |
| Decreased white blood cell count | 78 (20.1) | 33 (16.8) | 33 (8.5) | 17 (8.7) |
| Decreased neutrophil count | 77 (19.8) | 35 (17.9) | 55 (14.1) | 27 (13.8) |
| Decreased platelet count | 59 (15.2) | 36 (18.4) | 24 (6.2) | 16 (8.2) |
| Hypothyroidism | 58 (14.9) | 5 (2.6) | 1 (0.3) | 0 |
| Nausea | 50 (12.9) | 28 (14.3) | 1 (0.3) | 0 |
| Increased alanine aminotransferase level | 46 (11.8) | 19 (9.7) | 4 (1.0) | 1 (0.5) |
| Hyperthyroidism | 44 (11.3) | 6 (3.1) | 0 | 0 |
| Increased aspartate aminotransferase level | 38 (9.8) | 21 (10.7) | 2 (0.5) | 2 (1.0) |
| Decreased lymphocyte count | 26 (6.7) | 8 (4.1) | 8 (2.1) | 2 (1.0) |
| Neutropenia | 25 (6.4) | 10 (5.1) | 17 (4.4) | 9 (4.6) |
| Hyperglycemia | 24 (6.2) | 6 (3.1) | 8 (2.1) | 0 |
| Leukopenia | 21 (5.4) | 9 (4.6) | 10 (2.6) | 4 (2.0) |
| Hyponatremia | 17 (4.4) | 5 (2.6) | 9 (2.3) | 2 (1.0) |
a
Adverse events related to serplulimab or placebo.
b
Adverse events related to serplulimab or placebo. Adverse events were graded according to version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.
c
Occurred in 10% or greater of patients in either group.
d
Occurred in 2% or greater of patients in either group.