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 | ||||||
| Events | 194 | 212 | 368 | 457 | ||
| Patients, n (%) | 44 (91.7) | 45 (80.4) | 0.16 | 101 (91.8) | 97 (90.7) | 0.81 |
| SAE | ||||||
| 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) | 17 (15.5) | 24 (22.4) | ||
| Septic shock | 1 (2.1) | 1 (1.8) | 9 (8.2) | 17 (15.9) | ||
| Nervous system disorders (any) | 3 (6.3) | 0 (0) | 6 (5.5) | 7 (6.5) | ||
| Cardiac disorders (any) | 10 (20.8) | 10 (17.9) | 22 (20.0) | 17 (15.9) | ||
| 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) | 12 (10.9) | 13 (12.1) | ||
| Respiratory, thoracic, and mediastinal disorders (any) | 13 (27.1) | 6 (10.7) | 12 (10.9) | 11 (10.3) | ||
| 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) | 5 (4.5) | 2 (1.9) | ||
| Hepatobiliary disorders (any) | 0 (0) | 1 (1.8) | 5 (4.5) | 3 (2.8) | ||
| Renal and urinary disorders (any) | 3 (6.3) | 0 (0) | 0 (0) | 2 (1.9) | ||
| General disorders and administration site conditions (any) | 7 (14.6) | 11 (19.6) | 18 (16.4) | 16 (15.0) | ||
| Multi-organ failure | 6 (12.5) | 10 (17.9) | 17 (15.5) | 15 (14.0) | ||
AT II, angiotensin II; NED, norepinephrine-equivalent dose; SAE, serious adverse event; TEAE, treatment-emergent adverse event
*For each event category, patients were counted once even if they had multiple events within that category. Adverse events were coded according to the Medical Dictionary for Regulatory Activities