Table 3.

Summary of adverse events and serious adverse 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)
Deaths due to TEAEs4 (3.9)5 (4.8)3 (2.9)4 (3.8)12 (3.8)16 (3.8)
SAEa38 (36.9)44 (41.9)37 (35.9)41 (39.0)122 (39.0)160 (38.5)
TEAE93 (90.3)90 (85.7)90 (87.4)90 (85.7)270 (86.3)363 (87.3)
Study drug discontinuation due to TEAEs9 (8.7)5 (4.8)6 (5.8)12 (11.4)23 (7.3)32 (7.7)
  • All data are represented as n (%). TEAE, treatment emergent adverse event; SAE, serious adverse event.

  • a SAEs are treatment emergent SAEs.