Abstract 210 Table 1

Exposure-adjusted TEAE rates by dose (DBPC set)

Atacicept
Placebo, n=48325 mg, n=12975 mg, n=384150 mg, n=572All, n=1085Total, n=1568
Total number of patient-years278.351.5225.0286.7563.2841.4
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)
Infections211 (107.8)43 (104.4)180 (118.7)281 (141.3)504 (128.7)715 (121.7)
 Herpes zoster13 (4.7)2 (3.9)10 (4.5)17 (6.1)29 (5.2)42 (5.1)
 Serious infection20 (7.3)1 (1.9)23 (10.5)22 (7.7)46 (8.3)66 (7.9)
 Severe infection9 (3.2)011 (4.9)16 (5.6)27 (4.8)36 (4.3)
Injection site reactions54 (20.9)27 (64.8)109 (63.0)156 (72.4)292 (67.9)346 (50.2)
Severe hypogammaglobulinemia (IgG <3 g/L)002 (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 arrhythmias5 (1.8)04 (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)05 (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*01 (1.9)1 (0.4)3 (1.1)5 (0.9)5 (0.6)
Serious TEAE51 (18.9)15 (30.0)51 (23.9)61 (21.8)127 (23.4)178 (21.9)
Severe TEAE28 (10.2)10 (19.6)45 (20.9)56 (20.0)111 (20.3)139 (17.0)
Discontinuation of treatment due to TEAE30 (10.9)14 (27.6)30 (13.4)46 (16.1)90 (16.1)120 (14.3)
Deaths related to infections, n (%)
Deaths0002 (0.3) 00
  • *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)