Table 4.

Adverse events

	Obeticholic acid (n=141)	Placebo (n=142)
Composite cardiovascular events
Cardiovascular death or non-fatal myocardial infarction or non-fatal stroke	3	1
Other coronary artery disease or angina	2	2
Other†	8*	6
Neurological events (excluding stroke)
Dizziness or syncope	3	4*
Headache	2	5*
Neuralgia	3	2
Other‡	5	10*
Renal events
Urinary tract infection or cystitis	2	3
Kidney stones	6	2
Other§	2	2
Pruritus
Grade 1 (mild or localised)	9	6
Grade 2 (intense or widespread)	21*	3
Grade 3 (intense or widespread and interfering with activities of daily living)	3*	0
Any	33	9
Hepatobiliary events (excluding pruritus)	1	1
Gastrointestinal events
Abdominal pain	7	9*
Dental or tooth pain	4	1
Liver pain post biopsy	1	1
Nausea, vomiting, or diarrhoea	12	12*
Constipation	5	1
Dyspepsia	3	1
Pancreatitis	1	2
Other¶	9*	4

^*Includes one or more serious or life-threatening events described in the text.

^†Congestive heart failure, cardiomyopathy, or arrhythmia.

^‡Neuropathy, ataxia, insomnia, or restlessness.

^§Incontinence, pain, acute renal failure, or urine colour change.

^¶Small bowel obstruction, dehydration, haemorrhoids, distension, benign polyp removal, oesophageal injury, blood in stool, appendicitis, melaena, diverticulitis, anorexia, or painful bowel movement.