Table 3 Risk factors for occurence of serious adverse events in patients receiving triple therapy
No SAE (N = 80) | SAE (N = 22) | P-Value | |
|---|---|---|---|
Number (%) | Number (%) | ||
Mean (±SD) | Mean (±SD) | ||
Median (range) | Median (range) | ||
Male sex | 50 (62.5%) | 13 (59.1%) | 0.81 |
Age [years] | 46.7 (±12.4) | 53.5 (±7.3) | 0.02 |
Age > 50 years | 32 (40%) | 16 (72.7%) | <0.01 |
Liver cirrhosis | 17 (23.9%) | 12 (57.1%) | <0.01 |
Diabetes mellitus type 2 | 8 (10%) | 5 (22.7%) | 0.15 |
Psychiatric disorders | 16 (20%) | 4 (18.2%) | 1 |
Exclusion criteria for registration trials | 48 (60%) | 17 (77.3%) | 0.210 |
Drug | 0.45 | ||
Telaprevir | 49 (61.3%) | 16 (72.7%) | |
Boceprevir | 31 (38.8%) | 6 (27.3%) | |
Baseline laboratory | |||
Hemoglobin [g/dl] | 14.7 (10.3-18.8) | 14.6 (12.3-18.0) | 0.69 |
Leukocytes [x10^9/l] | 6.2 (3.1-13.1) | 5.9 (2.7-9.5) | 0.79 |
Platelets [x10^9/l] | 199.5 (85–377) | 127 (48–329) | <0.01 |
ASAT [U/l] | 49.5 (16–156) | 67.5 (26–328) | 0.04 |
ALAT [U/l] | 70 (16–255) | 91 (22–271) | 0.28 |
γGT [U/l] | 62.5 (57–1274) | 72 (25–459) | 0.18 |
Bilirubin [mg/dl] | 0.5 (0.2-1.5) | 0.75 (0.2-2.2) | 0.01 |
Albumin [g/l] | 40 (29–50) | 39 (25–44) | 0.11 |
Prothrombin time [INR] | 1.00 (0.9-3.3) | 1.13 (1.0-2.3) | <0.01 |
Creatinine [mg/dl] | 0.8 (0.5-5.8) | 0.8 (0.5-1.1) | 0.97 |
Platelets < 100,000/μl | 5 (6.3%) | 6 (27.3%) | 0.01 |
ASAT > 100 U/l | 11 (13.8%) | 8 (36.4%) | 0.03 |
Bilirubin ≥ 1.2 mg/dl | 2 (2.5%) | 6 (27.3%) | <0.01 |
Albumin ≤ 35 g/l | 3 (3.8%) | 4 (18.2%) | 0.04 |
Prothrombin time [INR] > 1.2 | 4 (5.3%) | 3 (13.6%) | 0.17 |