Table 3.
Safety parameter (number of patients with AE) | Terlipressin (n = 56) n (%) | Placebo (n = 55) n (%) |
---|---|---|
AEs up to 7 days posttreatment | ||
All | 52 (92.9) | 49 (89.1) |
Related | 18 (32.1) | 12 (21.8) |
Serious AEs up to 30 days posttreatment | ||
All | 37 (66.1) | 36 (65.5) |
Related | 5 (8.9) | 1 (1.8) |
Deaths up to 30 days posttreatment | ||
All | 27 (48.2) | 27 (49.1) |
Related | 0 (0.0) | 0 (0.0) |
Withdrawals because of AEs up to 7 days | ||
All | 3 (5.4) | 2 (3.6) |
Related | 3 (5.4) | 0 (0.0) |
AEs, adverse events.