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 TEAE | 8 (100.0) | 9 (100.0) | 12 (100.0) | 8 (80.0) | 7 (87.5) | 23 (100.0) |
Anemia | 1 (12.5) | 3 (33.3) | 2 (16.7) | 1 (10.0) | 2 (25.0) | 4 (17.4) |
Agitation | 2 (25.0) | 2 (22.2) | 1 (8.3) | 3 (30.0) | 1 (12.5) | 4 (17.4) |
Constipation | 2 (25.0) | 2 (22.2) | 2 (16.7) | 1 (10.0) | 0 | 6 (26.1) |
Generalized edema | 0 | 1 (11.1) | 3 (25.0) | 2 (20.0) | 3 (37.5) | 3 (13.0) |
Hypoglycemia | 1 (12.5) | 1 (11.1) | 1 (8.3) | 4 (40.0) | 3 (37.5) | 2 (8.7) |
Hypokalemia | 2 (25.0) | 1 (11.1) | 0 | 2 (20.0) | 0 | 7 (30.4) |
Hypernatremia | 1 (12.5) | 1 (11.1) | 0 | 3 (30.0) | 2 (25.0) | 2 (8.7) |
Hypophosphatemia | 2 (25.0) | 1 (11.1) | 0 | 2 (20.0) | 1 (12.5) | 2 (8.7) |
Diarrhea | 2 (25.0) | 0 | 0 | 1 (10.0) | 1 (12.5) | 4 (17.4) |
Edema peripheral | 2 (25.0) | 0 | 0 | 0 | 1 (12.5) | 4 (17.4) |
Insomnia | 1 (12.5) | 2 (22.2) | 0 | 1 (10.0) | 0 | 2 (8.7) |
Sepsis | 1 (12.5) | 0 | 3 (25.0) | 0 | 0 | 1 (4.3) |
Wheezing | 1 (12.5) | 2 (22.2) | 0 | 1 (10.0) | 0 | 1 (4.3) |
Bradycardia | 0 | 0 | 0 | 2 (20.0) | 0 | 3 (13.0) |
Feeding disorder | 1 (12.5) | 2 (22.2) | 0 | 0 | 0 | 1 (4.3) |
Decubitus ulcer | 1 (12.5) | 0 | 0 | 2 (20.0) | 1 (12.5) | 0 |
Hypertension | 0 | 1 (11.1) | 0 | 2 (20.0) | 1 (12.5) | 0 |
Scleral hemorrhage | 2 (25.0) | 0 | 0 | 0 | 0 | 0 |