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Table 2 Main results of historical comparison (simeprevir + PegIFNα-2a + RBV vs. PegIFNα-2a + RBV)
| Number of patients with event/total number of patients (%) | Relative risk (95 % CI) | Risk difference (95 % CI) | ||
|---|---|---|---|---|
| Simeprevir + PegIFNα-2a + RBV | PegIFNα-2a + RBV | |||
| Efficacy | ||||
| SVR24 (random effects) | 77/106 (72.6 %) | 104/369 (28.2 %) | 2.58 (2.11; 3.15) | 0.45 (0.34; 0.55) |
| SVR24 (fixed effects) | 364/1313 (27.7 %) | 2.62 (2.27; 3.03) | 0.45 (0.36; 0.54) | |
| Safety | ||||
| At least one AEa | 103/106 (97.2 %) | 396/410 (96.6 %) | 1.01 (0.97; 1.04) | 0.01 (−0.04; 0.05) |
| At least one SAEa | 11/106 (10.4 %) | 67/407 (16.5 %) | 0.63 (0.35; 1.15) | −0.06 (−0.14; 0.01) |
| AEs leading to discontinuationb | 5/106 (4.7 %) | 21/135 (15.6 %) | 0.30 (0.12; 0.78) | −0.11 (−0.19; −0.03) |
| Anemia AEs (random effects) | 35/106 (33.0 %) | 58/202 (28.7 %) | 1.15 (0.81; 1.63) | 0.04 (−0.07; 0.16) |
| Anemia AEs (fixed effects) | 124/418 (29.7 %) | 1.11 (0.82; 1.52) | 0.03 (−0.07; 0.14) | |
| Psychiatric disorders AEsc | 63/106 (59.4 %) | 3/10 (30.0 %) | 1.98 (0.76; 5.17) | 0.29 (−0.06; 0.65) |
