| Incidence, number (%) | ITC results | ||||||
---|---|---|---|---|---|---|---|---|
COMBI-v | coBRIM | |||||||
AE type | D + T (n = 350) | V (n = 349) | V (n = 246) | V + C (n = 247) | RR | LCI | UCI | p value |
Any AE | 345(98.6) | 345(98.9) | 240(97.6) | 244(98.8) | 0.98 | 0.96 | 1.01 | 0.3078 |
Any serious AE | 151(43.1) | 136(39.0) | 64(26.0) | 85(34.4) | 0.84 | 0.60 | 1.16 | 0.2835 |
Any treatment-related AE | 320(91.4) | 342(98.0) | 232(94.3) | 237(96.0) | 0.92 | 0.87 | 0.97 | 0.0015 |
AE leading to death | 4(1.1) | 4(1.2) | 3(1.2) | 5(2.0) | 0.60 | 0.08 | 4.35 | 0.6137 |
Any grade ≥3 AE | 199 (56.9) | 232 (66.5) | 146 (59.4) | 176 (71.3) | 0.71 | 0.60 | 0.85 | 0.0002 |
Any dose interruptions/modifications | 192(54.9) | 197(56.5) | 87(35.4) | 110(44.5) | 0.77 | 0.60 | 1.00 | 0.0471 |
Discontinuation due to AE | 55(15.7) | 48(13.8) | 20(8.1) | 37(15.0) | 0.62 | 0.33 | 1.16 | 0.1350 |