Before Dose 3 | After Dose 3 | |||||
---|---|---|---|---|---|---|
Mixed Motavizumab/Palivizumab (n = 83) | Mixed Palivizumab/Motavizumab (n = 83) | Motavizumab Only (n = 93) | Mixed Motavizumab/Palivizumab (n = 78a) | Mixed Palivizumab/Motavizumab (n = 82a) | Motavizumab Only (n = 92a) | |
AEs, n | 175 | 186 | 204 | 230 | 222 | 255 |
Subjects reporting, n (%) | ||||||
≥1 AE | 66 (79.5) | 64 (77.1) | 69 (74.2) | 70 (89.7) | 68 (82.9) | 71 (77.2) |
≥1 Level 3 AE as highest severity | 3 (3.6) | 3 (3.6) | 1 (1.1) | 10 (12.8) | 3 (3.7) | 5 (5.4) |
≥1 Level 4 AE | 3 (3.6)b | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0 (0.0) | 3 (3.3)b |
≥1 Related AE | 13 (15.7) | 9 (10.8) | 13 (14.0) | 6 (7.7) | 11 (13.4) | 15 (16.3) |
≥1 SAE | 10 (12.0) | 4 (4.8) | 6 (6.5) | 12 (15.4) | 5 (6.1) | 6 (6.5) |
≥1 Related SAE | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.1) |
≥1 AE resulting in discontinuation of study drug | 2 (2.4)c | 0 (0.0) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) |
Death | 2 (2.4) | 0 (0.0) | 1 (1.1)d | 0 (0.0) | 0 (0.0) | 0 (0.0) |