Table 5.

Adverse events and laboratory abnormalities by cirrhosis status

	No cirrhosis N = 573	Cirrhosis N = 120	Total N = 693
Adverse event, n (%)
Any AE	412 (72)	95 (79)	507 (73)
Serious AE	16 (3)	6 (5)	22 (3)
Serious AE related to study drugsa	0	0	0
AE leading to study drug discontinuation	3 (1)	0	3 (<1)
AE occurring in ≥10% of total patients
Headache	131 (23)	21 (18)	152 (22)
Fatigue	102 (18)	24 (20)	126 (18)
Nausea	68 (12)	13 (11)	81 (12)
Deaths	1 (<1)b	0	1 (<1)
Laboratory abnormalitiesc, n (%)
Alanine aminotransferase
Grade 2 (>3‐5 ×  ULN)	2 (<1)	2 (2)	4 (1)
Grade ≥3 (>5 ×  ULN)	2 (<1)	0	2 (<1)
Aspartate aminotransferase
Grade ≥3 (>5 ×  ULN)	2 (<1)	0	2 (<1)
Total bilirubin
Grade ≥3 (>5 ×  ULN)	2 (<1)	2 (2)	4 (1)

AE, adverse event.

ALT must have been post nadir increase in grade.

^aRelation to study drugs as assessed by investigator.

^bAccidental overdose in the post‐treatment period, unrelated to study drug.

^cNo grade 4 laboratory abnormalities were observed.