Study of INT-747 as Monotherapy in Participants With Prim... | NCT00570765

ID	Type	Description	Link
2007-001424-12	EudraCT Number

Label	Type	Description	Intervention Names
DB OCA 10 mg	Experimental	OCA 10 mg for 3 months during the DB phase.	Drug: Obeticholic Acid (OCA)
DB OCA 50 mg	Experimental	OCA 50 mg for 3 months during the DB phase.	Drug: Obeticholic Acid (OCA)
DB OCA Placebo	Placebo Comparator	Matching placebo for 3 months during the DB phase.	Drug: Placebo
LTSE OCA Total	Experimental	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.	Drug: Obeticholic Acid (OCA)

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Matching placebo tablets were administered orally once daily.	DB OCA Placebo

Measure	Description	Time Frame
DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85	The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.	Baseline, Day 85

Measure	Description	Time Frame
DB Phase: Mean Percent Change In Gamma-glutamyl Transferase (GGT) From Baseline To Day 85	As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to Day 85 is reported.	Baseline, Day 85
DB Phase: Mean Percent Change In Alanine Transaminase (ALT) From Baseline To Day 85

Name	Affiliation	Role
Christian Weyer, MD	Intercept Pharmaceuticals, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford		Detroit	Michigan	48202	United States
Baylor College of Medicine

PubMed Identifier	Type	Citation	Retractions
29023915	Background	Kowdley KV, Luketic V, Chapman R, Hirschfield GM, Poupon R, Schramm C, Vincent C, Rust C, Pares A, Mason A, Marschall HU, Shapiro D, Adorini L, Sciacca C, Beecher-Jones T, Bohm O, Pencek R, Jones D; Obeticholic Acid PBC Monotherapy Study Group. A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis. Hepatology. 2018 May;67(5):1890-1902. doi: 10.1002/hep.29569. Epub 2018 Jan 29.

ID	Title	Description
FG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase.
FG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85

The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.

Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.

Posted

Mean

Standard Deviation

Percent change

Baseline, Day 85

ID	Title	Description
OG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG00020 OG00116 OG00223

Title

Denominators

Categories

Title	Measurements
	OG000-44.5± 24.4 OG001-37.6± 21.0 OG0020.4± 15.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002	Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.	Wilcoxon (Mann-Whitney)	Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.	<0.0001						2-Sided	95

Secondary

DB Phase: Mean Percent Change In Gamma-glutamyl Transferase (GGT) From Baseline To Day 85

As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to Day 85 is reported.

Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.

Posted

Mean

Standard Deviation

Percent change

Baseline, Day 85

ID	Title	Description
OG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Secondary

DB Phase: Mean Percent Change In Alanine Transaminase (ALT) From Baseline To Day 85

As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to Day 85 is reported.

Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.

Posted

Mean

Standard Deviation

Percent change

Baseline, Day 85

ID	Title	Description
OG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Secondary

DB: Plasma Trough Concentrations Of OCA And Its Major, Known Metabolites

OCA and its conjugates were quantified by an assay using an extended and improved protocol initially described in peer reviewed literature. The assay was not validated when the study was conducted. A validated assay was established using plasma after the study. But because only serum samples, not plasma samples, were acquired in the study, the levels of OCA and its conjugates were not summarized in the clinical study report, and thus, not used to draw conclusions on exposure.

Posted

12 weeks

ID	Title	Description
OG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Secondary

DB Phase: Mean Percent Change In Conjugated Bilirubin From Baseline To Day 85

As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to Day 85 is reported.

Intention-to-treat (ITT): participants randomized to receive investigational product regardless of their actual treatment status.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Day 85

ID	Title	Description
OG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
OG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Secondary

LTSE Phase: Median Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit

The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline (DB), Month 24, Month 48, Month 72, Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE Phase: Mean Percent Change In Serum ALP From Baseline To Month 24, Month 48, Month 72, And Last Available Visit

The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Mean

Standard Deviation

Percent Change

Baseline (DB), Month 24, Month 48, Month 72, Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Median Percent Change In GGT From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Mean Percent Change In GGT From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Mean

Standard Deviation

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Median Percent Change In ALT From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Mean Percent Change In ALT From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Mean

Standard Deviation

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Median Percent Change In Conjugated Bilirubin From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA (PO QD). Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Mean Percent Change In Conjugated Bilirubin From Baseline To Last Available Visit

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Mean

Standard Deviation

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA (PO QD). Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Median Percent Change In Total Bilirubin From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in total bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA (PO QD). Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Secondary

LTSE: Mean Percent Change In Total Bilirubin From Baseline To Last Available Visit

As a marker of hepatocellular injury and liver function, the percent change in total bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.

Safety Population: participants who received at least 1 dose of open-label investigational product during the LTSE phase.

Posted

Mean

Standard Deviation

Percent Change

Baseline (DB), Last Available Visit (up to 96 months)

ID	Title	Description
OG000	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA (PO QD). Doses up to 50 mg daily were evaluated.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG00024 events14 affected20 at risk EG00122 events15 affected16 at risk EG00211 events7 affected23 at risk EG003107 events25 affected28 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0012 events2 affected16 at risk EG0021 events1 affected23 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0024 events4 affected23 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0011 events1 affected16 at risk EG0021 events1 affected23 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0012 events2 affected16 at risk EG0021 events1 affected23 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0025 events4 affected23 at risk EG003
Fatigue	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0023 events3 affected23 at risk EG003
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0005 events4 affected20 at risk EG0013 events2 affected16 at risk EG0026 events5 affected23 at risk EG003
Influenza like illness	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0022 events2 affected23 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.1	Systematic Assessment		EG0002 events1 affected20 at risk EG0012 events2 affected16 at risk EG0021 events1 affected23 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0003 events3 affected20 at risk EG0011 events1 affected16 at risk EG0022 events2 affected23 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0014 events4 affected16 at risk EG0025 events4 affected23 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0003 events3 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0011 events1 affected16 at risk EG0021 events1 affected23 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lymphoid tissue hyperplasia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Palpitations	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Dry eye	Eye disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0021 events1 affected23 at risk EG003
Cataract	Eye disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Iritis	Eye disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0012 events2 affected16 at risk EG0020 events0 affected23 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0022 events2 affected23 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0012 events2 affected16 at risk EG0020 events0 affected23 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0012 events2 affected16 at risk EG0020 events0 affected23 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0021 events1 affected23 at risk EG003
Coeliac disease	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Faeces pale	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0012 events2 affected16 at risk EG0020 events0 affected23 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Salivary gland enlargement	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0022 events2 affected23 at risk EG003
Chest discomfort	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Chills	General disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Feeling cold	General disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0003 events2 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Bronchitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Influenza	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Ear infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Tooth infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Eye infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Laryngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Otitis media	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rhinitis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Weight decreased	Investigations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Cardiac murmur	Investigations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
White blood cells urine	Investigations	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0022 events2 affected23 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Muscle spasm	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Migraine	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Aphonia	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Facial neuralgia	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0020 events0 affected23 at risk EG003
Irregular sleep phase	Nervous system disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	This adverse event affected only female participants.	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected20 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	This adverse event affected only female participants.	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected20 at risk EG003
Breast tenderness	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	This adverse event affected only female participants.	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected20 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0021 events1 affected23 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0021 events1 affected23 at risk EG003
Spider naevus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0011 events1 affected16 at risk EG0022 events1 affected23 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0002 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0002 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Varicose vein	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003
Hot flush	Vascular disorders	MedDRA 12.1	Systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected16 at risk EG0020 events0 affected23 at risk EG003

ID	Term
D002780	Cholestasis, Intrahepatic
D002779	Cholestasis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D008107	Liver Diseases
D008103	Liver Cirrhosis
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
BG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
BG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase. After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB OCA 10 mg	OCA 10 mg for 3 months during the DB phase.	0	20	18	20
EG001	DB OCA 50 mg	OCA 50 mg for 3 months during the DB phase.	0	16	15	16
EG002	DB OCA Placebo	Matching placebo for 3 months during the DB phase.	1	23	19	23
EG003	LTSE OCA Total	After completion of the 3-month DB phase, all eligible participants were offered the opportunity to enter an open-label LTSE for up to 96 months beginning at 10 mg OCA. Doses up to 50 mg daily were evaluated.	9	28	28	28