Table 4.

AEs (safety analysis set)

Arm 1, n=115Arm 2, n=45Arm 3, n=47Arm 4, n=119Arm 5, n=105
Subjects with, no. (%)
 ≥1 AE112 (97.4)41 (91.1)46 (97.9)116 (97.5)103 (98.1)
 ≥1 Serious AE48 (41.7)21 (46.7)28 (59.6)50 (42.0)43 (41.0)
 ≥1 AE leading to death3 (2.6)4 (8.9)5 (10.6)4 (3.4)5 (4.8)
 ≥1 Treatment-related AE9 (7.8)5 (11.1)6 (12.8)18 (15.1)12 (11.4)
 ≥1 AE leading to study drug discontinuation1 (0.9)1 (2.2)002 (1.9)
Patients with a predefined surgical complication, no. (%)
 Stroke0002 (1.7)2 (1.9)
 Myocardial infarction4 (3.5)2 (4.4)02 (1.7)4 (3.8)
 Surgical site infection0001 (0.8)1 (1.0)
 Nonsurgical site infection2 (1.7)03 (6.4)4 (3.4)2 (1.9)
 Prolonged ventilation6 (5.2)6 (13.3)3 (6.4)9 (7.6)6 (5.7)
 Dialysis2 (1.7)1 (2.2)2 (4.3)1 (0.8)4 (3.8)
 Low-cardiac output syndrome14 (12.2)4 (8.9)7 (14.9)13 (10.9)13 (12.4)
  • Arm 1 indicates placebo. Arm 2 =0.02-mg/kg preoperative and postoperative doses. Arm 3 =0.12-mg/kg preoperative and 0.02-mg/kg postoperative doses. Arm 4 =0.46-mg/kg preoperative and 0.02-mg/kg postoperative doses. Arm 5 =0.46-mg/kg preoperative and postoperative doses.