AST 0 1 (8.3) 2 (16.7) 0 Haemoglobin 0 0 2 (16.7) 1 (9.1) TBIL 1 (8.3) 1 (8.3) 1 (8.3) 0 Lipase 0 1 ( 8.3) 0 0 Platelets 0 0 1 (8.3) 0 ALT, alanine aminotransferase; AST, aspartate aminotransferase; TBIL, total bilirubin; WBC, white blood cell. Serious adverse events Deaths: There were no deaths reported in Stage 1. Other SAEs: 5 subjects reported SAEs, 2 (16.7%) subjects each in the ASV 200 mg BD and ASV 600 mg QD groups and 1 in the ASV 600 mg BD group. No SAEs led to discontinuation of study therapy. Table 9: Study AI447016: Other serious adverse events. Stage 1 enrolled subjects – Treatment Preferred Onset and Group to Study Duration Therapy a 200-mg BD Not Onset: OT Study drug not ASV Grade 3 related Week 32 interrupted, treatment 54 year old Duration: required male 266 days 50 year old Abdominal Not OT Study drug not male Pain/Grade 2 related Week 1 interrupted, treatment Duration: 8 required days 600-mg BD Goitre/Grade 2 Not Onset: OT drug not ASV related Week 48 interrupted, treatment 54 year old Duration: 56 required Black female days 600-mg QD Hepatocellular Related Onset: OT Study drug not ASV injury/Grade 3 Week 6 interrupted, treatment not 69 year old Duration: 42 required White male days
AST 0 1 (8.3) 2 (16.7) 0 Haemoglobin 0 0 2 (16.7) 1 (9.1) TBIL 1 (8.3) 1 (8.3) 1 (8.3) 0 Lipase 0 1 ( 8.3) 0 0 Platelets 0 0 1 (8.3) 0 ALT, alanine aminotransferase; AST, aspartate aminotransferase; TBIL, total bilirubin; WBC, white blood cell. Serious adverse events Deaths: There were no deaths reported in Stage 1. Other SAEs: 5 subjects reported SAEs, 2 (16.7%) subjects each in the ASV 200 mg BD and ASV 600 mg QD groups and 1 in the ASV 600 mg BD group. No SAEs led to discontinuation of study therapy. Table 9: Study AI447016: Other serious adverse events. Stage 1 – enrolled subjects Treatment Group Preferred to Study Therapy a Onset and Duration 200-mg BD ASV 54 year old male Grade 3 Not related Onset: OT Week 32 Duration: 266 days Study drug not interrupted, treatment required 50 year old male Abdominal Pain/Grade 2 Not related OT Week 1 Duration: 8 days Study drug not interrupted, treatment required 600-mg BD ASV 54 year old Black female Goitre/Grade 2 Not related Onset: OT Week 48 Duration: 56 days drug not interrupted, treatment required 600-mg QD ASV 69 year old White male Hepatocellular injury/Grade 3 Related Onset: OT Week 6 Duration: 42 days Study drug not interrupted, treatment not required
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