Table 2.
Safety and clinical status of the pediatric safety population
| WBD | Fixed dosing | All | |||||
|---|---|---|---|---|---|---|---|
| BAM + ETE (n = 94) |
Pbo (n = 14) |
350/700 BAM + ETE (n = 6) |
700/1400 BAM + ETE (n = 10) |
2800/2800 BAM + ETE (n = 4) |
Pooled BAM + ETE (n = 114) |
Total (N = 128) |
|
| Serious adverse event (SAE) | 1 (1.1) | 0 | 0 | 0 | 0 | 1 (0.9) | 1 (0.8) |
| Overall treatment-emergent adverse event (TEAE) | 17 (18.1) | 0 | 1 (16.7) | 1 (10.0) | 0 | 19 (16.7) | 19 (14.8) |
| TEAE by severity | |||||||
| Mild | 10 (10.6) | 0 | 0 | 0 | 0 | 10 (8.8) | 10 (7.8) |
| Moderate | 6 (6.4) | 0 | 1 (16.7) | 1 (10.0) | 0 | 8 (7.0) | 8 (6.3) |
| Severe | 1 (1.1)a | 0 | 0 | 0 | 0 | 1 (0.9) | 1 (0.8)a |
| TEAE in ≥ 5% of participants | |||||||
| Blood creatine phosphokinase increase | 6 (6.4) | 0 | 0 | 0 | 0 | 6 (5.3) | 6 (4.7) |
| White blood cell count decrease | 5 (5.3) | 0 | 0 | 0 | 0 | 5 (4.4) | 5 (3.9) |
| Infusion site extravasation | 0 | 1 (16.7) | 0 | 0 | 1 (0.9) | 1 (0.8) | |
| Hypersensitivity (rash)b | 0 | 0 | 0 | 1 (10.0) | 0 | 1 (0.9) | 1 (0.8) |
| Discontinuation from study due to adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COVID-19-related hospitalization, day 85 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COVID-19-related emergency room visit | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Death from any cause | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
BAM + ETE bamlanivimab and etesevimab, Pbo placebo, WBD weight-based dosing
aThe severe TEAE was an increase in blood creatine phosphokinase on Day 1. The increase was reduced by 50% on Day 3 and had normalized by Day 29
bRash was reported > 24 h after BAM + ETE infusion and was the only hypersensitivity reaction reported in the study