Table 3.
Any grade treatment-related adverse events (> 20% in the PIC group).
| TRAEs | PIC | Chemotherapy | Risk ratio [95% CI] | P | ||
|---|---|---|---|---|---|---|
| Event/total | % | Event/total | % | |||
| Leukopenia | 257/353 | 72.80% | 134/178 | 75.28% | 0.97 [0.87, 1.07] | 0.53 |
| Alopecia | 315/500 | 63.00% | 154/256 | 60.16% | 1.08 [0.96, 1.22] | 0.18 |
| Anaemia | 280/500 | 56.00% | 132/256 | 51.56% | 1.05 [0.92, 1.21] | 0.48 |
| Neutrophil count decreased | 80/147 | 54.42% | 39/78 | 50.00% | 1.02 [0.79, 1.32] | 0.88 |
| Neutropenia | 266/500 | 53.20% | 123/256 | 48.05% | 1.08 [0.95, 1.23] | 0.26 |
| White blood cell count decreased | 67/147 | 45.58% | 30/78 | 38.46% | 1.44 [0.41, 5.02] | 0.57 |
| AST increased | 165/387 | 42.64% | 92/209 | 44.02% | 0.92 [0.77, 1.11] | 0.41 |
| ALT increased | 163/387 | 42.12% | 93/209 | 44.50% | 0.91 [0.75, 1.10] | 0.34 |
| Nasopharyngitis | 11/34 | 32.35% | 3/31 | 9.68% | 3.34 [1.03, 10.88] | 0.05 |
| Nausea | 161/500 | 32.20% | 60/256 | 23.44% | 1.39 [1.08, 1.78] | 0.01 |
| Asthenia | 111/353 | 31.44% | 39/178 | 21.91% | 1.44 [1.05, 1.97] | 0.03 |
| Decreased platelet count | 31/113 | 27.43% | 11/47 | 23.40% | 1.17 [0.64, 2.13] | 0.60 |
| Hypertriglyceridemia | 91/353 | 25.78% | 53/178 | 29.78% | 0.87 [0.65, 1.15] | 0.32 |
| Dysgeusia | 8/34 | 23.53% | 9/31 | 29.03% | 0.81 [0.36, 1.84] | 0.61 |
| Rash | 116/500 | 23.20% | 53/256 | 20.70% | 1.13 [0.85, 1.51] | 0.41 |
| Stomatitis | 34/147 | 23.13% | 9/78 | 11.54% | 2.00 [1.02, 3.95] | 0.04 |
| Constipation | 114/500 | 22.80% | 49/256 | 19.14% | 1.20 [0.89, 1.63] | 0.23 |
| Fatigue | 33/147 | 22.45% | 17/78 | 21.79% | 1.02 [0.61, 1.72] | 0.93 |
| Decreased appetite | 112/500 | 22.40% | 43/256 | 16.80% | 1.34 [0.97, 1.85] | 0.08 |
| Hypoesthesia | 75/353 | 21.25% | 24/178 | 13.48% | 1.58 [1.03, 2.41] | 0.04 |
| Nail discoloration | 7/34 | 20.59% | 9/31 | 29.03% | 0.71 [0.30, 1.67] | 0.43 |
| Paronychia | 7/34 | 20.59% | 0/31 | 0.00% | 13.71 [0.82, 230.61] | 0.07 |
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.