Table 4.

Summary of adjudicated renal and death events

VariablePlacebo (n=103)TGF-β1 mAbAll Active (n=313)Total (n=416)
2 mg (n=105)10 mg (n=103)50 mg (n=105)
ESRD9 (8.7)6 (5.7)5 (4.9)12 (11.4)23 (7.3)32 (7.7)
AKI4 (3.9)9 (8.6)5 (4.9)5 (4.8)19 (6.1)23 (5.5)
Deaths4 (3.9)5 (4.8)3 (2.9)4 (3.8)12 (3.8)16 (3.8)
 Coronary ischemia1 (0.97)3 (2.9)1 (0.97)4 (1.3)5 (1.2)
 Sudden or cardiac arrest1 (0.95)1 (0.32)1 (0.24)
 Heart failure2 (1.9)2 (1.9)1 (0.95)3 (0.96)5 (1.2)
 Stroke1 (0.95)1 (0.32)1 (0.24)
 Cancer1 (0.95)1 (0.32)1 (0.24)
 Hypoglycemia1 (0.95)1 (0.32)1 (0.24)
 Respiratory failure1 (0.95)1 (0.32)1 (0.24)
 Sepsis1 (0.97)1 (0.24)
  • All data are represented as n (%).