Table 4 Summary of safety events
|  | Low-NED (≤ 0.25 µg/kg/min) | p-value | High-NED (> 0.25 µg/kg/min) | p-value | ||
|---|---|---|---|---|---|---|
Placebo (n = 48) | AT II (n = 56) | Placebo (n = 110) | AT II (n = 107) | |||
TEAE | Â | Â | Â | Â | Â | Â |
  Events | 194 | 212 |  | 368 | 457 |  |
  Patients, n (%) | 44 (91.7) | 45 (80.4) | 0.16 | 101 (91.8) | 97 (90.7) | 0.81 |
SAE | Â | Â | Â | Â | Â | Â |
  Events | 51 | 53 |  | 116 | 118 |  |
  Patients, n (%) | 32 (66.7) | 27 (48.2) | 0.07 | 74 (67.3) | 72 (67.3) | 1.0 |
SAE with frequency ≥ 4% in any study group, n (%)* |  |  |  |  |  |  |
Infections and infestations (any) | 4 (8.3) | 6 (10.7) | Â | 17 (15.5) | 24 (22.4) | Â |
  Septic shock | 1 (2.1) | 1 (1.8) |  | 9 (8.2) | 17 (15.9) |  |
Nervous system disorders (any) | 3 (6.3) | 0 (0) | Â | 6 (5.5) | 7 (6.5) | Â |
Cardiac disorders (any) | 10 (20.8) | 10 (17.9) | Â | 22 (20.0) | 17 (15.9) | Â |
  Atrial fibrillation | 2 (4.2) | 0 (0) |  | 3 (2.7) | 5 (4.7) |  |
  Cardiac arrest | 3 (6.3) | 2 (3.6) |  | 6 (5.5) | 5 (4.7) |  |
  Ventricular tachycardia | 1 (2.1) | 3 (5.4%) |  | 2 (1.8) | 2 (1.9) |  |
Vascular disorders (any) | 3 (6.3) | 4 (7.1) | Â | 12 (10.9) | 13 (12.1) | Â |
Respiratory, thoracic, and mediastinal disorders (any) | 13 (27.1) | 6 (10.7) | Â | 12 (10.9) | 11 (10.3) | Â |
  Acute respiratory failure | 5 (10.4) | 0 (0) |  | 0 (0) | 3 (2.8) |  |
  Respiratory failure | 7 (14.6) | 3 (5.4) |  | 4 (3.6) | 5 (4.7) |  |
Gastrointestinal disorders (any) | 3 (6.3) | 1 (1.8) | Â | 5 (4.5) | 2 (1.9) | Â |
Hepatobiliary disorders (any) | 0 (0) | 1 (1.8) | Â | 5 (4.5) | 3 (2.8) | Â |
Renal and urinary disorders (any) | 3 (6.3) | 0 (0) | Â | 0 (0) | 2 (1.9) | Â |
General disorders and administration site conditions (any) | 7 (14.6) | 11 (19.6) | Â | 18 (16.4) | 16 (15.0) | Â |
  Multi-organ failure | 6 (12.5) | 10 (17.9) |  | 17 (15.5) | 15 (14.0) |  |