Table 2.

AEs of grade 3 or greater severity reported in at least two subjects in any treatment group (safety analysis set, n=333)

Adverse EventPlacebo (n=85)Selonsertib 2 mg (n=81)Selonsertib 6 mg (n=84)Selonsertib 18 mg (n=83)
Any AE of grade 3 or greater severity, n (%)15 (17.6)21 (25.9)20 (23.8)21 (25.3)
 AKI2 (2.4)1 (1.2)3 (3.6)1 (1.2)
 Cardiac failure, congestive2 (2.4)1 (1.2)1 (1.2)3 (3.6)
 Cellulitis1 (1.2)1 (1.2)2 (2.4)2 (2.4)
 Pneumonia01 (1.2)1 (1.2)2 (2.4)
 Dyspnea1 (1.2)02 (2.4)1 (1.2)
 ESRD2 (2.4)02 (2.4)0
 Acute myocardial infarction01 (1.2)2 (2.4)0
 Hyperkalemia001 (1.2)2 (2.4)
 Hypertension1 (1.2)2 (2.5)00
 Chronic obstructive pulmonary disease02 (2.5)00
 Renal failure02 (2.5)00
 CKD2 (2.4)000
  • AEs were mapped according to MedDRA Version 19. Treatment-emergent AEs are those that started on or after first study drug dose date up to and including 30 d after permanent discontinuation, or that led to premature study drug discontinuation. Severity grades (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) were from modified CTCAE Version 4.0. Multiple AEs were counted once per subject for each preferred term. CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities.