Safety, Tolerability, and Efficacy of GS-4997 Alone or in... | NCT02466516

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEL 6 mg	Experimental	Selonsertib (SEL) 6 mg for 24 weeks.	Drug: SEL
SEL 18 mg	Experimental	SEL 18 mg for 24 weeks.	Drug: SEL
SEL 6 mg+SIM 125 mg	Experimental	SEL 6 mg plus SIM 125 mg for 24 weeks.	Drug: SEL Biological: SIM
SEL 18 mg+SIM 125 mg	Experimental	SEL 18 mg plus SIM 125 mg for 24 weeks.	Drug: SEL Biological: SIM
SIM 125 mg	Experimental	SIM 125 mg for 24 weeks.	Biological: SIM

Name	Type	Description	Arm Group Labels	Other Names
SEL	Drug	SEL tablet administered orally once daily	SEL 18 mg SEL 18 mg+SIM 125 mg SEL 6 mg SEL 6 mg+SIM 125 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality	Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.	Baseline up to last dose plus 30 days (up to Week 28)
Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events		Baseline up to follow up visit (Week 28)

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Palo Alto	California	94304	United States
University of California San Diego

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Loomba R, Lawitz E, Mantry PS, Jayakumar S, Caldwell SH, Arnold H, et al. GS-4997, an inhibitor of apoptosis signal-regulating kinase (ASK1), alone or in combination with simtuzumab for the treatment of nonalcoholic steatohepatitis (NASH): a randomized, phase 2 trial. Hepatol 2016; 64 (6S): 1119A-1120A.
	Result	Diehl AM, French D, Xu R, et al. Treatment with selonsertib, an inhibitor of apoptosis signal-regulating kinase 1, hepatic phospho-p38 expression and markers of hepatocellular apoptosis and necrosis in patients with nonalcoholic steatohepatitis. J Hepatol 2017;66:S51. PS-090.
	Result	Middleton MS, Lawitz E, Jayakumar S, et al. Hepatic proton density fat fraction correlates with histologic measures of steatosis and is responsive to change in those measures in a multi-center nonalcoholic steatohepatitis clinical trial. J Hepatol 2017;66:S668. SAT-483.
	Result	Loomba R, Lawitz E, Ghalib R, et al. Longitudinal changes in liver stiffness by magnetic resonance elastography (MRE), liver fibrosis, and serum markers of fibrosis in a multi-center clinical trial in nonalcoholic steatohepatitis (NASH). J Hepatol 2017;66:S671. SAT-489.

Results Section

Participant Flow Module

ID	Title	Description
FG000	SEL 6 mg	Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
FG001	SEL 18 mg	SEL 18 mg tablet once daily for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	SEL 6 mg	Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
BG001	SEL 18 mg	SEL 18 mg tablet once daily for 24 weeks.
BG002	SEL 6 mg+SIM 125 mg	SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
BG003	SEL 18 mg+SIM 125 mg	SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
BG004	SIM 125 mg	SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054± 11.5 BG00156± 9.0 BG00252± 9.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00013 BG00115 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG0017 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Asian	BG0003 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0003 BG0011 BG002

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

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality

Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Safety Analysis Set included all participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline up to last dose plus 30 days (up to Week 28)

ID	Title	Description
OG000	SEL 6 mg	Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
OG001	SEL 18 mg	SEL 18 mg tablet once daily for 24 weeks.
OG002	SEL 6 mg+SIM 125 mg	SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
OG003	SEL 18 mg+SIM 125 mg	SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
OG004	SIM 125 mg	SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.

Units	Counts
Participants	OG00020 OG00122 OG00210 OG003

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG00017 OG00115 OG0029 OG003

Primary

Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events

Participants in the Safety Analysis Set were analyzed.

Posted

Count of Participants

Participants

Baseline up to follow up visit (Week 28)

ID	Title	Description
OG000	SEL 6 mg	Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.
OG001	SEL 18 mg	SEL 18 mg tablet once daily for 24 weeks.
OG002	SEL 6 mg+SIM 125 mg	SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.
OG003	SEL 18 mg+SIM 125 mg	SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.
OG004	SIM 125 mg	SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SEL 6 mg	Selonsertib (SEL) 6 mg tablet once daily for 24 weeks.	20	2	20	17	20
EG001	SEL 18 mg	SEL 18 mg tablet once daily for 24 weeks.	22	2	22	14	22
EG002	SEL 6 mg+SIM 125 mg	SEL 6 mg tablet once daily plus simtuzumab (SIM) 125 mg/mL administered subcutaneously once weekly for 24 weeks.	10	0	10	9	10
EG003	SEL 18 mg+SIM 125 mg	SEL 18 mg tablet once daily plus SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.	10	1	10	9	10
EG004	SIM 125 mg	SIM 125 mg/mL administered subcutaneously once weekly for 24 weeks.	10	0	10	7	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG0030 affected10 at risk EG0040 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Influenza	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Sepsis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG0030 affected10 at risk EG004
Abdominal distension	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0014 affected22 at risk EG0020 affected10 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0021 affected10 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Infrequent bowel movements	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0003 affected20 at risk EG0014 affected22 at risk EG0021 affected10 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Palatal swelling	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Chest discomfort	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Chest pain	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Chills	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Fatigue	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Hernia pain	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Injection site bruising	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Injection site erythema	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Injection site pain	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Oedema	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Pain	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Peripheral swelling	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Pyrexia	General disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected10 at risk EG003
Ear infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Fungal infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Gingivitis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Herpes zoster	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Influenza	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Localised infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0003 affected20 at risk EG0012 affected22 at risk EG0021 affected10 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0022 affected10 at risk EG003
Tooth abscess	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0023 affected10 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Blood cholesterol increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Blood glucose increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Blood pressure increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
International normalised ratio increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Transaminases increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Weight increased	Investigations	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0021 affected10 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0021 affected10 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0020 affected10 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected10 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Amnesia	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Headache	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0003 affected20 at risk EG0017 affected22 at risk EG0021 affected10 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Sciatica	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Somnolence	Nervous system disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Abnormal dreams	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Irritability	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0002 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected10 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0022 affected10 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected10 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Flushing	Vascular disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0012 affected22 at risk EG0020 affected10 at risk EG003
Hot flush	Vascular disorders	MedDRA Version 19.1	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003
Hypotension	Vascular disorders	MedDRA Version 19.1	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0020 affected10 at risk EG003

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D005355	Fibrosis

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms