Table 2

Most frequent treatment-emergent AEs and most frequent treatment-related AEs (>1 subject in placebo or total mavrilimumab groups) (safety population)

AE, n (%)Placebo (n=79)Mavrilimumab
10 mg (n=39)30 mg (n=41)50 mg (n=40)100 mg (n=40)Total (n=160)
Total number of AEs7439403729145
Total subjects reporting ≥1 AE36 (45.6)25 (64.1)24 (58.5)19 (47.5)23 (57.5)91 (56.9)
Carbon monoxide diffusing capacity decreased5 (6.3)10 (25.6)3 (7.3)3 (7.5)3 (7.5)19 (11.9)
Nasopharyngitis2 (2.5)1 (2.6)4 (9.8)1 (2.5)4 (10.0)10 (6.3)
Upper respiratory tract infection4 (5.1)2 (5.1)1 (2.4)1 (2.5)2 (5.0)6 (3.8)
Worsening of rheumatoid arthritis2 (2.5)2 (5.1)1 (2.4)2 (5.0)0 (0)5 (3.1)
Transaminases increased0 (0)1 (2.6)1 (2.4)1 (2.5)1 (2.5)4 (2.5)
Alanine aminotransferase increased0 (0)0 (0)2 (4.9)1 (2.5)1 (2.5)4 (2.5)
Pharyngitis0 (0)0 (0)1 (2.4)2 (5.0)1 (2.5)4 (2.5)
Oral herpes0 (0)1 (2.6)2 (4.9)0 (0)0 (0)3 (1.9)
Hypercholesterolemia1 (1.3)1 (2.6)1 (2.4)1 (2.5)0 (0)3 (1.9)
Neutropenia0 (0)0 (0)2 (4.9)1 (2.5)0 (0)3 (1.9)
Influenza1 (1.3)1 (2.6)0 (0)2 (5.0)0 (0)3 (1.9)
Hepatic enzyme increased2 (2.5)1 (2.6)0 (0)0 (0)1 (2.5)2 (1.3)
Injection site pain0 (0)0 (0)1 (2.4)0 (0)1 (2.5)2 (1.3)
Anemia4 (5.1)1 (2.6)0 (0)0 (0)1 (2.5)2 (1.3)
Bronchitis1 (1.3)0 (0)0 (0)0 (0)2 (5.0)2 (1.3)
Amenorrhea0 (0)1 (2.6)0 (0)0 (0)1 (2.5)2 (1.3)
Skin exfoliation0 (0)1 (2.6)0 (0)1 (2.5)0 (0)2 (1.3)
Monocytopenia2 (2.5)0 (0)0 (0)0 (0)1 (2.5)1 (0.6)
Hypertension2 (2.5)0 (0)1 (2.4)0 (0)0 (0)1 (0.6)
Rash2 (2.5)0 (0)1 (2.4)0 (0)0 (0)1 (0.6)
Cough2 (2.5)0 (0)0 (0)0 (0)0 (0)0 (0)
Treatment-related adverse events
 Total subjects reporting ≥1 related AE11 (13.9)8 (20.5)9 (22.0)8 (20.0)7 (17.5)32 (20.0)
 Carbon monoxide diffusing capacity decreased1 (1.3)4 (10.3)2 (4.9)1 (2.5)0 (0)7 (4.4)
 Upper respiratory tract infection1 (1.3)0 (0)0 (0)1 (2.5)2 (5.0)3 (1.9)
 Neutropenia0 (0)0 (0)2 (4.9)1 (2.5)0 (0)3 (1.9)
 Worsening of rheumatoid arthritis0 (0)0 (0)1 (2.4)1 (2.5)0 (0)2 (1.3)
 Transaminases increased0 (0)0 (0)0 (0)1 (2.5)1 (2.5)2 (1.3)
 Hepatic enzyme increased2 (2.5)1 (2.6)0 (0)1 (2.5)0 (0)1 (0.6)
Serious adverse events
 Total subjects reporting ≥1 related SAE122000
  • AE, adverse event; SAE, serious adverse event.