Table 7.
Summary of treatment-emergent adverse events and deaths (safety analysis set).
| Parameter, n (%) | ASP0113 (n = 246) | Placebo (n = 255) |
|---|---|---|
| TEAEs | 246 (100) | 255 (100) |
| Drug-related⁎ TEAEs | 194 (78.9) | 74 (29.0) |
| SAEs | 221 (89.8) | 221 (86.7) |
| Drug-related⁎ serious TEAEs | 22 (8.9) | 13 (5.1) |
| TEAEs leading to death | 61 (24.8) | 63 (24.7) |
| Drug-related⁎ TEAEs leading to death | 4 (1.6) | 1 (0.4) |
| TEAEs leading to permanent discontinuation of the study drug | 48 (19.5) | 45 (17.6) |
| Drug-related TEAEs leading to permanent discontinuation of the study drug | 5 (2.0) | 4 (1.6) |
| Deaths† | 67 (27.2) | 68 (26.7) |
⁎
Possible or probable, as assessed by the investigator, or records where relationship is missing.
†
Deaths listed here are those from transplant through to the day after Day 380. AE=adverse event; SAE=serious adverse event; TEAE=treatment-emergent adverse event.