Skip to main content
. 2018 Jan 4;67(2):514–523. doi: 10.1002/hep.29541

Table 4.

AEs and Key Laboratory Abnormalities

Arm A (12 Weeks G/P) Arm B (16 Weeks G/P)
1:1 Randomized
Event, n (%) Treatment‐Naive With Cirrhosis (n = 40) Treatment‐Experienced Without Cirrhosis (n = 22) Treatment‐experienced Without Cirrhosis (n = 22) Treatment‐Experienced With Cirrhosis (n = 47)
Any AE 32 (80) 12 (55) 17 (77) 34 (72)
Serious AE 1 (3) 1 (5) 1 (5) 3 (6)
Serious AE related to study drugs 0 0 0 0
AE leading to study drug d/c 0 0 0 0
AEs occurring in ≥ 10% of patients
Fatigue 5 (13) 4 (18) 4 (18) 16 (34)
Headache 10 (25) 5 (23) 4 (18) 6 (13)
Key laboratory abnormalities,a n (%)
ALTb
Grade ≥ 3 (>5 × ULN) 0 2 (9) 0 0
Total bilirubin
Grade ≥ 3 (>3 × ULN) 0 0 0 1 (2)
a

Laboratory abnormalities based on the Common Terminology Criteria for Adverse Events, version 4.

b

ALT must have been increased post nadir in grade.

Abbreviations: d/c, discontinuation; ULN, upper limit of normal.