Atacicept | ||||||
---|---|---|---|---|---|---|
Placebo, n=483 | 25 mg, n=129 | 75 mg, n=384 | 150 mg, n=572 | All, n=1085 | Total, n=1568 | |
Total number of patient-years | 278.3 | 51.5 | 225.0 | 286.7 | 563.2 | 841.4 |
TEAE, n (per 100 patient-years) | ||||||
Hypersensitivity* | 37 (13.9) | 8 (15.7) | 40 (19.1) | 55 (20.4) | 103 (19.4) | 140 (17.6) |
Infections | 211 (107.8) | 43 (104.4) | 180 (118.7) | 281 (141.3) | 504 (128.7) | 715 (121.7) |
Herpes zoster | 13 (4.7) | 2 (3.9) | 10 (4.5) | 17 (6.1) | 29 (5.2) | 42 (5.1) |
Serious infection | 20 (7.3) | 1 (1.9) | 23 (10.5) | 22 (7.7) | 46 (8.3) | 66 (7.9) |
Severe infection | 9 (3.2) | 0 | 11 (4.9) | 16 (5.6) | 27 (4.8) | 36 (4.3) |
Injection site reactions | 54 (20.9) | 27 (64.8) | 109 (63.0) | 156 (72.4) | 292 (67.9) | 346 (50.2) |
Severe hypogammaglobulinemia (IgG <3 g/L) | 0 | 0 | 2 (0.9) | 4 (1.4) | 6 (1.1) | 6 (0.7) |
Cardiac arrhythmias [all]* | 18 (6.6) | 11 (22.4) | 23 (10.6) | 25 (8.9) | 59 (10.8) | 77 (9.4) |
Ventricular arrhythmias | 5 (1.8) | 0 | 4 (1.8) | 6 (2.1) | 10 (1.8) | 15 (1.8) |
Ischemic heart disorders* | 11 (4.0) | 3 (5.9) | 13 (5.9) | 11 (3.9) | 27 (4.9) | 38 (4.6) |
Embolic and thromboembolic events* | 11 (4.0) | 1 (2.0) | 6 (2.7) | 9 (3.2) | 16 (2.9) | 27 (3.2) |
Vestibular disorders* | 19 (7.0) | 5 (9.9) | 18 (8.3) | 26 (9.3) | 49 (8.9) | 68 (8.3) |
Demyelination* | 1 (0.4) | 1 (1.9) | 0 | 5 (1.7) | 6 (1.1) | 7 (0.8) |
Depression* | 14 (5.1) | 3 (5.8) | 8 (3.6) | 11 (3.9) | 22 (3.9) | 36 (4.3) |
Malignant tumor* | 0 | 1 (1.9) | 1 (0.4) | 3 (1.1) | 5 (0.9) | 5 (0.6) |
Serious TEAE | 51 (18.9) | 15 (30.0) | 51 (23.9) | 61 (21.8) | 127 (23.4) | 178 (21.9) |
Severe TEAE | 28 (10.2) | 10 (19.6) | 45 (20.9) | 56 (20.0) | 111 (20.3) | 139 (17.0) |
Discontinuation of treatment due to TEAE | 30 (10.9) | 14 (27.6) | 30 (13.4) | 46 (16.1) | 90 (16.1) | 120 (14.3) |
Deaths related to infections, n (%) | ||||||
Deaths | 0 | 0 | 0 | 2 (0.3)† | 0 | 0 |
*Programmatically determined (crude results of the search) from a predefined list of MedDRA preferred terms according to the Standardized MedDRA Query (SMQ) or Customized MedDRA Query (CMQ) classification of the corresponding MedDRA version
†Acute respiratory failure and probable leptospirosis (n=1); pneumonia and pulmonary alveolar hemorrhage (n=1)