Table 4.
Overview of TEAEs (SAF)
| Category | Placebo (n = 11) | Bleselumab dose (mg/kg) | ||||
|---|---|---|---|---|---|---|
| 0.1 (n = 20) | 0.3 (n = 10) | 1.0 (n = 10) | 3.0 (n = 9) | Total (n = 49) | ||
| TEAE | 9 (81.8) | 16 (80.0) | 9 (90.0) | 9 (90.0) | 9 (100) | 43 (87.8) |
| Drug‐related* TEAE | 8 (72.7) | 6 (30.0) | 6 (60.0) | 3 (30.0) | 8 (88.9) | 23 (46.9) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious TEAE | 1 (9.1) | 2 (10.0) | 0 | 1 (10.0) | 1 (11.1) | 4 (8.2) |
| Drug‐related* serious TEAE | 0 | 0 | 0 | 1 (10.0) | 1 (11.1) | 2 (4.1) |
| TEAE leading to permanent discontinuation of study drug | 0 | 0 | 0 | 1 (10.0) | 1 (11.1) | 2 (4.1) |
| Drug‐related* TEAE leading to permanent discontinuation of study drug | 0 | 0 | 0 | 1 (10.0) | 1 (11.1) | 2 (4.1) |
Data are reported as n (%).
*
Possibly or probably drug related, as assessed by the investigator, or records where the relationship was missing. SAF, safety‐analysis set; TEAE, treatment‐emergent adverse event.