TABLE 4.
Summary of treatment-emergent adverse events reported
| TEAE | 0.33 mg/kg (n = 6) |
0.66 mg/kg (n = 6) |
1 mg/kg (n = 6) |
All active (n = 18) |
Placebo (n = 7) |
Total (n = 25) |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. (%) of subjects | No. of events | No. (%) of subjects | No. of events | No. (%) of subjects | No. of events | No. (%) of subjects | No. of events | No. (%) of subjects | No. of events | No. (%) of subjects | No. of events | |
| Blood creatine phosphokinase increased | 1 (16.7) | 1 | 1 (16.7) | 1 | 3 (50.0) | 3 | 5 (27.8) | 5 | 0 | 0 | 5 (20.0) | 5 |
| Hemoglobin decreased | 1 (16.7) | 1 | 0 | 0 | 2 (33.3) | 2 | 3 (16.7) | 3 | 1 (14.3) | 1 | 4 (16.0) | 4 |
| Hematuria | 0 | 0 | 0 | 0 | 1 (16.7) | 1 | 1 (5.6) | 1 | 2 (28.6) | 3 | 3 (12.0) | 4 |
| Hematocrit decreased | 1 (16.7) | 1 | 0 | 0 | 2 (33.3) | 2 | 3 (16.7) | 3 | 0 | 0 | 3 (12.0) | 3 |
| Viral upper respiratory tract infection | 2 (33.3) | 2 | 1 (16.7) | 1 | 0 | 0 | 3 (16.7) | 3 | 0 | 0 | 3 (12.0) | 3 |
| White blood cell count decreased | 1 (16.7) | 1 | 1 (16.7) | 1 | 1 (16.7) | 1 | 3 (16.7) | 3 | 0 | 0 | 3 (12.0) | 3 |
| Blood calcium decreased | 1 (16.7) | 1 | 0 | 0 | 0 | 0 | 1 (5.6) | 1 | 1 (14.3) | 1 | 2 (8.0) | 2 |
| Blood potassium increased | 2 (33.3) | 2 | 0 | 0 | 0 | 0 | 2 (11.1) | 2 | 0 | 0 | 2 (8.0) | 2 |
| Blood sodium increased | 1 (16.7) | 1 | 0 | 0 | 0 | 0 | 1 (5.6) | 1 | 1 (14.3) | 1 | 2 (8.0) | 2 |
| Cough | 0 | 0 | 1 (16.7) | 1 | 1 (16.7) | 1 | 2 (11.1) | 2 | 0 | 0 | 2 (8.0) | 2 |
| Hypernatremia | 0 | 0 | 2 (33.3) | 2 | 0 | 0 | 2 (11.1) | 2 | 0 | 0 | 2 (8.0) | 2 |
| Myalgia | 1 (16.7) | 1 | 0 | 0 | 1 (16.7) | 1 | 2 (11.1) | 2 | 0 | 0 | 2 (8.0) | 2 |
| Neutrophil count decreased | 0 | 0 | 1 (16.7) | 1 | 1 (16.7) | 1 | 2 (11.1) | 2 | 0 | 0 | 2 (8.0) | 2 |
| Proteinuria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (28.6) | 2 | 2 (8.0) | 2 |
| Total TEAEs | 11 | 7 | 12 | 8 | 38 | |||||||