Table 4.

Adverse events and medication discontinuation

			Ursodeoxycholic acid (n=304)	Placebo (n=300)
Serious adverse events*			2	6
System organ class of serious adverse events
	Congenital, familial, and genetic disorders		0	1
	Hepatobiliary disorders		0	1
	Infections and infestations		1	1
	Metabolism and nutrition disorders		0	1
	Pregnancy, puerperium, and perinatal conditions		1	1
	Reproductive system and breast disorders		0	1
Adverse events			31	41
	Not related to study intervention		15	31
	Possibly related to study intervention		8	9
	Probably related to study intervention		1	0
	Missing data		7	1
System organ class of adverse events
	Blood and lymphatic system disorders		4	4
	Gastrointestinal disorders		10	10
	Pregnancy, puerperium, and perinatal conditions		7	18
	Other		10	9
Discontinued intervention			24/304 (8%)	29/300 (10%)
	Clinician decision		10/24 (42%)	10/29 (34%)
		Consultant wanted participant to receive ursodeoxycholic acid	3/10 (30%)	2/10 (20%)
		Increased bile acids or alanine transaminase, or itch, or both	6/10 (60%)	8/10 (80%)
		Nausea, vomiting, or upset stomach	1/10 (10%)	0
	Participant decision		16/24 (67%)	22/29 (76%)
		Itch improved or manageable without medication	1/13 (8%)	1/19 (5%)
		Did not want medication or did not collect medication	5/13 (39%)	4/19 (21%)
		Increased bile acids or alanine transaminase, or itch, or both	6/13 (46%)	8/19 (42%)
		Nausea, vomiting, or upset stomach	1/13 (8%)	2/19 (11%)
		Stopped trial drug for a week	0	1/19 (5%)
		Wanted ursodeoxycholic acid	0	3/19 (16%)
		Not known	3	3
Action after discontinuation
	Prescribed ursodeoxycholic acid		17/23 (74%)	21/27 (78%)
	Not prescribed ursodeoxycholic acid		6/23 (26%)	6/27 (22%)
	Not known		1	2

Data are number of events or n/N (%). Adverse events and serious adverse events were classified according to system organ class terminology.²⁰

^*None of the serious adverse events were related to the study intervention.