Table 3– Adverse events reported overall and by ≥5% of subjects in any treatment group (safety population)
Adverse eventPlacebo#Tralokinumab
Combined tralokinumab150 mg300 mg600 mg
Subjects47146475148
At least one adverse event17 (36.2)70 (47.9)20 (42.6)25 (49.0)25 (52.1)
Asthma3 (6.4)16 (11.0)5 (10.6)5 (9.8)6 (12.5)
Headache2 (4.3)13 (8.9)6 (12.8)1 (2.0)6 (12.5)
Nasopharyngitis4 (8.5)10 (6.8)3 (6.4)3 (5.9)4 (8.3)
Bacteriuria0 (0.0)8 (5.5)2 (4.3)2 (3.9)4 (8.3)
Decreased neutrophil count3 (6.4)6 (4.1)3 (6.4)1 (2.0)2 (4.2)
Influenza-like illness2 (4.3)6 (4.1)1 (2.1)2 (3.9)3 (6.3)
Urinary tract infection0 (0.0)6 (4.1)3 (6.4)1 (2.0)2 (4.2)
Crystalluria0 (0.0)5 (3.4)1 (2.1)1 (2.0)3 (6.3)
Diarrhoea0 (0.0)5 (3.4)0 (0.0)0 (0.0)5 (10.4)
Decreased lymphocyte count3 (6.4)4 (2.7)2 (4.3)1 (2.0)1 (2.1)
Eosinophilia1 (2.1)4 (2.7)1 (2.1)0 (0.0)3 (6.3)
Bronchitis3 (6.4)3 (2.1)2 (4.3)1 (2.0)0 (0.0)
  • Data are presented as n or n (%). The adverse events are ordered by frequency in combined tralokinumab group. #: one subject did not receive study medication; : increase in asthma symptoms or asthma exacerbations.