Table 6 Serious treatment-emergent adverse events, irrespective of relationship to study drug (safety population)*
AZD9773 cohort 1 (50 U/kg) (n= 8) | AZD9773 cohort 2 (250 U/kg) (n= 9) | AZD9773 cohort 3 (250/50 U/kg) (n= 12) | AZD9773 cohort 4 (500/100 U/kg) (n= 10) | AZD9773 cohort 5 (750/250 U/kg) (n= 8) | Placebo (n= 23) | |
|---|---|---|---|---|---|---|
Patients with any serious TEAE | 3 (37.5) | 6 (66.7) | 7 (58.3) | 3 (30.0) | 4 (50.0) | 13 (56.5) |
Sepsis | 1 (12.5) | 0 | 3 (25.0) | 0 | 0 | 1 (4.3) |
Pneumonia | 1 (12.5) | 1 (11.1) | 0 | 0 | 0 | 2 (8.7) |
Septic shock | 0 | 1 (11.1) | 0 | 0 | 1 (12.5) | 2 (8.7) |
Respiratory failure | 0 | 0 | 0 | 2 (20.0) | 0 | 2 (8.7) |
Cardiac arrest | 1 (12.5) | 1 (11.1) | 0 | 0 | 0 | 1 (4.3) |
Pulmonary embolism | 0 | 1 (11.1) | 0 | 0 | 1 (12.5) | 1 (4.3) |
Deep vein thrombosis | 0 | 0 | 1 (8.3) | 1 (10.0) | 0 | 1 (4.3) |
Hemorrhagic shock | 0 | 0 | 1 (8.3) | 0 | 0 | 1 (4.3) |
Empyema | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
Endocarditis | 0 | 1 (11.1) | 0 | 0 | 0 | 0 |
Cellulitis | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Acute myocardial infarction | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
Cardiac failure | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
Supraventricular tachycardia | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
Atrial fibrillation | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Pneumonia aspiration | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
Hypoxia | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Shock | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
Peripheral ischemia | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Enterocutaneous fistula | 0 | 0 | 0 | 0 | 1 (12.5) | 0 |
Intestinal ischemia | 0 | 0 | 0 | 0 | 1 (12.5) | 0 |
Intestinal perforation | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Medical device complication | 0 | 1 (11.1) | 0 | 0 | 0 | 0 |
Acidosis | 0 | 1 (11.1) | 0 | 0 | 0 | 0 |
Malignant lung neoplasm | 0 | 1 (11.1) | 0 | 0 | 0 | 0 |
Cerebral infarction | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
Intracranial hemorrhage | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |
Toxic epidermal necrolysis | 1 (12.5) | 0 | 0 | 0 | 0 | 0 |
Muscle hemorrhage | 0 | 0 | 0 | 0 | 0 | 1 (4.3) |