Table 3.
Summary of adverse events and serious adverse 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) | ||||
| Deaths due to TEAEs | 4 (3.9) | 5 (4.8) | 3 (2.9) | 4 (3.8) | 12 (3.8) | 16 (3.8) |
| SAEa | 38 (36.9) | 44 (41.9) | 37 (35.9) | 41 (39.0) | 122 (39.0) | 160 (38.5) |
| TEAE | 93 (90.3) | 90 (85.7) | 90 (87.4) | 90 (85.7) | 270 (86.3) | 363 (87.3) |
| Study drug discontinuation due to TEAEs | 9 (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.