Table 3.
Safety Analysis through Day 28
| BMS mAbs n=105 | Placebo n=106 | Total n=211 | |
|---|---|---|---|
| Any TEAE, n (%) | 38 (36.2) | 36 (34.0) | 74 (35.1) |
| Grade 3 or higher TEAE, n (%) | 8 (7.6) | 14 (13.2) | 22 (10.4) |
| Serious TEAE, n (%) | 4 (3.8) | 3 (2.8) | 7 (3.3) |
| Study drug related TEAE, n (%) | 5 (4.8) | 2 (1.9) | 7 (3.3) |
| TEAE leading to study drug withdrawal, n (%) | 0 | 0 | 0 |
| TEAE with outcome of death, n (%) | 0 | 0 | 0 |
| TEAE of special interesta, n (%) | 1 (1.0) | 0 | 1 (0.5) |
BMS mAbs refers to subcutaneously administered BMS-986414 (C135-LS) 200 mg plus BMS-986413 (C144-LS) 200 mg.
Treatment-emergent adverse events (TEAEs) are defined as adverse events new in onset or aggravated in severity or frequency from the baseline condition following the start of study treatment, including events reported as adverse events and graded laboratory value escalations.
a
1 participant had a Grade 1 hypersensitivity TEAE of special interest.