Placebo (n = 145) | Quilizumab 150 mg Q (n = 145) | Quilizumab 450 mg Q (n = 145) | Quilizumab 300 mg M (n = 143) | All Quilizumab (n = 433) | |
---|---|---|---|---|---|
Any AE | 114 (78.6 %) | 110 (75.9 %) | 108 (74.5 %) | 103 (72.0 %) | 321 (74.1 %) |
Serious AE | 12 (8.3 %) | 11 (7.6 %) | 10 (6.9 %) | 16 (11.2 %) | 37 (8.5 %) |
Grade 3 AE or higher | 21 (14.5 %) | 28 (19.3 %) | 30 (20.7 %) | 24 (16.8 %) | 82 (18.9 %) |
Grade 2 AE or higher | 86 (59.3 %) | 78 (53.8 %) | 80 (55.2 %) | 82 (57.3 %) | 240 (55.4 %) |
Infections and infestations | 76 (52.4 %) | 73 (50.3 %) | 71 (49.0 %) | 68 (47.6 %) | 212 (49.0 %) |
Parasitic infections | 0 | 0 | 0 | 1 (0.7 %) | 1 (0.2 %) |
Serious infections | 3 (2.1 %) | 3 (2.1 %) | 1 (0.7 %) | 2 (1.4 %) | 6 (1.4 %) |
Injection site reactions | 12 (8.3 %) | 10 (6.9 %) | 13 (9.0 %) | 7 (4.9 %) | 30 (6.9 %) |
Serious injection site reactions | 0 | 0 | 0 | 0 | 0 |
AE leading to treatment withdrawal | 1 (0.7 %) | 4 (2.8 %) | 1 (0.7 %) | 1 (0.7 %) | 6 (1.4 %) |
Malignancies | 0 | 2 (1.4 %) | 2 (1.4 %) | 0 | 4 (0.9 %) |
Deaths | 0 | 0 | 0 | 0 | 0 |