Table 4.
Grade 3-5 treatment-related adverse events (> 2% in the PIC group).
| TRAEs | PIC | Chemotherapy | Risk ratio [95% CI] | P | ||
|---|---|---|---|---|---|---|
| Event/total | % | Event/total | % | |||
| Neutrophil count decreased | 59/147 | 40.14% | 28/78 | 35.90% | 0.98 [0.70, 1.37] | 0.89 |
| White blood cell count decreased | 40/147 | 27.21% | 21/78 | 26.92% | 0.86 [0.56, 1.32] | 0.50 |
| Leukopenia | 89/353 | 25.21% | 42/178 | 23.60% | 1.07 [0.78, 1.47] | 0.68 |
| Neutropenia | 115/500 | 23.00% | 58/256 | 22.66% | 0.98 [0.75, 1.29] | 0.90 |
| Decreased platelet count | 12/113 | 10.62% | 7/47 | 14.89% | 0.71 [0.30, 1.70] | 0.44 |
| Anaemia | 38/500 | 7.60% | 13/256 | 5.08% | 1.31 [0.73, 2.36] | 0.37 |
| AST increased | 23/387 | 5.94% | 4/209 | 1.91% | 2.86 [1.02, 8.05] | 0.05 |
| ALT increased | 21/387 | 5.43% | 5/209 | 2.39% | 2.11 [0.82, 5.47] | 0.12 |
| Hypoesthesia | 16/353 | 4.53% | 3/178 | 1.69% | 2.69 [0.79, 9.11] | 0.11 |
| Asthenia | 15/353 | 4.25% | 4/178 | 2.25% | 1.89 [0.64, 5.61] | 0.25 |
| Peripheral sensory neuropathy | 18/500 | 3.60% | 7/256 | 2.73% | 1.21 [0.53, 2.80] | 0.65 |
| Lymphopenia | 11/353 | 3.12% | 6/178 | 3.37% | 0.92 [0.35, 2.46] | 0.87 |
| Gamma-glutamyl transferase increased | 10/353 | 2.83% | 1/178 | 0.56% | 5.04 [0.65, 39.08] | 0.12 |
| Hypokalemia | 8/353 | 2.27% | 4/178 | 2.25% | 1.01 [0.31, 3.30] | 0.99 |
| Fatigue | 3/147 | 2.04% | 2/78 | 2.56% | 0.62 [0.11, 3.61] | 0.60 |
AE, Adverse event; ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; CI, Confidence interval; PD-1, Programmed death-1; PD-L1, Programmed death-ligand 1; PIC, PD-1/PD-L1 inhibitors plus chemotherapy; RR, Risk ratio; TRAE, Treatment-related adverse event.