Table 4.
Summary of adjudicated renal and death events
| Variable | Placebo (n=103) | TGF-β1 mAb | All Active (n=313) | Total (n=416) | ||
|---|---|---|---|---|---|---|
| 2 mg (n=105) | 10 mg (n=103) | 50 mg (n=105) | ||||
| ESRD | 9 (8.7) | 6 (5.7) | 5 (4.9) | 12 (11.4) | 23 (7.3) | 32 (7.7) |
| AKI | 4 (3.9) | 9 (8.6) | 5 (4.9) | 5 (4.8) | 19 (6.1) | 23 (5.5) |
| Deaths | 4 (3.9) | 5 (4.8) | 3 (2.9) | 4 (3.8) | 12 (3.8) | 16 (3.8) |
| Coronary ischemia | 1 (0.97) | 3 (2.9) | 1 (0.97) | 4 (1.3) | 5 (1.2) | |
| Sudden or cardiac arrest | 1 (0.95) | 1 (0.32) | 1 (0.24) | |||
| Heart failure | 2 (1.9) | 2 (1.9) | 1 (0.95) | 3 (0.96) | 5 (1.2) | |
| Stroke | 1 (0.95) | 1 (0.32) | 1 (0.24) | |||
| Cancer | 1 (0.95) | 1 (0.32) | 1 (0.24) | |||
| Hypoglycemia | 1 (0.95) | 1 (0.32) | 1 (0.24) | |||
| Respiratory failure | 1 (0.95) | 1 (0.32) | 1 (0.24) | |||
| Sepsis | 1 (0.97) | 1 (0.24) | ||||
All data are represented as n (%).