TABLE 3.

Incidence of adverse events (AEs) following a single dose of olaparib 300 mg (tablet formulation; part A) ^a

AE, n (%)	Normal hepatic function (n = 13)	Mild hepatic impairment (n = 10)	Moderate hepatic impairment (n = 8)	Total (n = 31)
Any AE	10 (76.9)	5 (50)	5 (62.5)	20 (64.5)
Nausea	4 (30.8)	0	0	4 (12.9)
Diarrhoea	3 (23.1)	0	0	3 (9.7)
Anaemia	1 (7.7)	1 (10)	2 (25)	3 (9.7)
Constipation	1 (7.7)	1 (10)	0	2 (6.5)
Abdominal pain	1 (7.7)	0	1 (12.5)	2 (6.5)
Asthenia	0	1 (10)	1 (12.5)	2 (6.5)
Pain in extremity	1 (7.7)	0	1 (12.5)	2 (6.5)
Mouth ulceration	1 (7.7)	0	0	1 (3.2)
Fatigue	1 (7.7)	0	0	1 (3.2)
Headache	1 (7.7)	0	0	1 (3.2)
Rash pruritic	1 (7.7)	0	0	1 (3.2)
Hepatic pain	0	1 (10)	0	1 (3.2)
Urinary tract infection	0	1 (10)	0	1 (3.2)
ALT increased	0	1 (10)	0	1 (3.2)
Hyperglycaemia	0	1 (10)	0	1 (3.2)
Erythema	0	1 (10)	0	1 (3.2)
Pruritus	0	1 (10)	0	1 (3.2)
Hypertension	0	1 (10)	0	1 (3.2)
Lymphopenia	0	0	1 (12.5)	1 (3.2)
Bilirubin increased	0	0	1 (12.5)	1 (3.2)
Decreased appetite	0	0	1 (12.5)	1 (3.2)
Muscle spasms	0	0	1 (12.5)	1 (3.2)
Insomnia	0	0	1 (12.5)	1 (3.2)
Renal failure	0	0	1 (12.5)	1 (3.2)
Any serious AE	1 (7.7)	0	1 (12.5)	2 (6.5)
Abdominal pain	1 (7.7)	0	0	1 (3.2)
Renal failure	0	0	1 (12.5)	1 (3.2)
Any AE of grade ≥ 3	0	1 (10)	2 (25)	3 (9.7)
Hypertension	0	1 (10)	0	1 (3.2)
Lymphopenia	0	0	1 (12.5)	1 (3.2)
Renal failure	0	0	1 (12.5)	1 (3.2)

AEs were coded according to Medical Dictionary for Regulatory Activities‐preferred terms.

^aGraded using CTCAE v4.0. ALT, alanine aminotransferase; CTCAE v4.0, Common Terminology Criteria for Adverse Events version 4.