Table 2

Treatment-emergent adverse events

Blisibimod (n=245)Placebo (n=196)Overall (n=441)
Subjects with any TEAE, n (%)
TEAE171 (69.8)127 (64.8)298 (67.6)
Serious TEAE32 (13.1)34 (17.3)66 (15.0)
Mild TEAE151 (61.6)110 (56.1)261 (59.2)
Moderate TEAE71 (29.0)63 (32.1)134 (30.4)
Severe TEAE16 (6.5)14 (7.1)30 (6.8)
TEAE related to study drug88 (35.9)46 (23.5)134 (30.4)
TEAE leading to discontinue13 (5.3)3 (1.5)16 (3.6)
TEAE leading to death1 (0.4)2 (1.0)3 (0.7)
TEAEs in>3% of subjects (overall), n (%)
Subjects with any TEAE171 (69.8)127 (64.8)298 (67.6)
Infections and infestations107 (43.7)86 (43.9)193 (43.8)
  Upper respiratory tract infection26 (10.6)28 (14.3)54 (12.2)
  Urinary tract infection17 (6.9)21 (10.7)38 (8.6)
  Influenza9 (3.7)9 (4.6)18 (4.1)
  Herpes zoster9 (3.7)7 (3.6)16 (3.6)
  Nasopharyngitis13 (5.3)3 (1.5)16 (3.6)
  Viral infection3 (1.2)10 (5.1)13 (2.9)
General disorders and administration site conditions60 (24.5)26 (13.3)86 (19.5)
  Injection site erythema19 (7.8)4 (2.0)23 (5.2)
  Injection site reaction18 (7.3)5 (2.6)23 (5.2)
Gastrointestinal disorders44 (18.0)31 (15.8)74 (17.0)
  Diarrhoea18 (7.3)5 (2.6)23 (5.2)
Musculoskeletal and connective tissue disorders34 (13.9)34 (17.3)68 (15.4)
  Back pain9 (3.7)5 (2.6)14 (3.2)
Nervous system disorders33 (13.5)35 (17.9)68 (15.4)
  Headache15 (6.1)16 (8.2)31 (7.0)
  Dizziness6 (2.4)6 (3.1)12 (2.7)
Investigations12 (4.9)20 (10.2)32 (7.3)
  Transaminases increased4 (1.6)6 (3.1)10 (2.3)
Blood and lymphatic system diseases11 (4.5)20 (10.2)31 (7.0)
  Anaemia3 (1.2)8 (4.1)11 (2.5)
Vascular disorders12 (4.9)13 (6.6)25 (5.7)
  Hypertension7 (2.9)13 (6.6)20 (4.5)
Treatment-emergent serious adverse events in>1 subject, n (%)
Infections and infestations15 (6.1)17 (8.7)32 (7.3)
  Pneumonia2 (0.8)6 (3.1)8 (1.8)
  Urinary tract infection2 (0.8)2 (1.0)4 (0.9)
  Appendicitis3 (1.2)03 (0.7)
  Sepsis1 (0.4)2 (1.0)3 (0.7)
  Cellulitis1 (0.4)1 (0.5)2 (0.5)
  Gastroenteritis02 (1.0)2 (0.5)
  Herpes zoster2 (0.8)02 (0.5)
  Pyelonephritis1 (0.4)1 (0.5)2 (0.5)
Musculoskeletal and connective tissue disorders5 (2.0)5 (2.6)10 (2.3)
  SLE1 (0.4)3 (1.5)4 (0.9)
Blood and lymphatic system disorders3 (1.2)4 (2.0)7 (1.6)
  Anaemia1 (0.4)1 (0.5)2 (0.5)
Gastrointestinal disorders2 (0.8)4 (2.0)6 (1.4)
  Upper gastrointestinal haemorrhage1 (0.4)1 (0.5)2 (0.5)
Vascular disorders3 (1.2)1 (0.5)4 (0.9)
  Deep vein thrombosis2 (0.8)02 (0.5)
Pregnancy, puerperium and perinatal conditions1 (0.4)2 (1.0)3 (0.7)
  Abortion spontaneous1 (0.4)2 (1.0)3 (0.7)
  • SLE, systemic lupus erythematosus; TEAE, treatment-emergent adverse event.