55 year old Sepsis/Grade 4 Not OT drug White female Septic Shock/Grade related Week 24 interrupted, 4 treatment Duration: 5 required days 53 year old Related OT Study drug White female b/ Grade 3 Week 10 discontinued, treatment not ALT Increased Duration: 4 required b/Grade 3 days AST Increased 4 Placebo Group 50 year old Bile Duct Not Onset: OT Study drug not White male Obstruction/Grade related Week 20 interrupted, 3 treatment Duration: 13 required days 48 year old Intervertebral Disc Not Onset: OT Study drug not male Protrusion/ Grade related Week 48 interrupted, 3 treatment Duration: 82 required days 57 year old Abdominal Not Onset: OT drug White female 2 related Week 16 interrupted, Vomiting/Grade 2 treatment Duration: 2 Musculoskeletal required days Pain/ Grade 2 a A determination of relatedness indicates that at 1 of the 3 drugs (ASV, pegIFNα, or RBV) was considered related to the event; relationship to study therapy as judged by the investigator b AE leading to discontinuation. Discontinuations due to AEs 13 subjects discontinued (any) study therapy due to AEs, with 12 discontinuing all study drugs (ASV/placebo, pegIFNα, and RBV). AEs leading to discontinuation were reported in a slightly higher proportion of subjects in the ASV group than the placebo group (5.6% vs 4.9%). The types of AEs leading to discontinuation were generally similar across the treatment groups. Each AE leading to discontinuation was reported by 1 subject in either group, except rash (2 subjects [1.1%] in the ASV group). Laboratory test abnormalities The most frequent Grade 3 to 4 laboratory abnormality was neutropenia (28.4% in the ASV/pegIFNα/RBV group versus 29.5% in the placebo group) an expected event with
55 year old White female Sepsis/Grade 4 Septic Shock/Grade 4 Not related OT Week 24 Duration: 5 days drug interrupted, treatment required 53 year old White female b/ Grade 3 ALT Increased b/Grade 3 AST Increased 4 Related OT Week 10 Duration: 4 days Study drug discontinued, treatment not required Placebo Group 50 year old White male Bile Duct Obstruction/Grade 3 Not related Onset: OT Week 20 Duration: 13 days Study drug not interrupted, treatment required 48 year old male Intervertebral Disc Protrusion/ Grade 3 Not related Onset: OT Week 48 Duration: 82 days Study drug not interrupted, treatment required 57 year old White female Abdominal 2 Vomiting/Grade 2 Musculoskeletal Pain/ Grade 2 Not related Onset: OT Week 16 Duration: 2 days drug interrupted, treatment required a A determination of relatedness indicates that at 1 of the 3 drugs (ASV, pegIFNα, or RBV) was considered related to the event; relationship to study therapy as judged by the investigator b AE leading to discontinuation. Discontinuations due to AEs 13 subjects discontinued (any) study therapy due to AEs, with 12 discontinuing all study drugs (ASV/placebo, pegIFNα, and RBV). AEs leading to discontinuation were reported in a slightly higher proportion of subjects in the ASV group than the placebo group (5.6% vs 4.9%). The types of AEs leading to discontinuation were generally similar across the treatment groups. Each AE leading to discontinuation was reported by 1 subject in either group, except rash (2 subjects [1.1%] in the ASV group). Laboratory test abnormalities The most frequent Grade 3 to 4 laboratory abnormality was neutropenia (28.4% in the ASV/pegIFNα/RBV group versus 29.5% in the placebo group) an expected event with