Study to Evaluate the Efficacy and Safety of CC-90001 in... | NCT04048876

ID	Type	Description	Link
U1111-1235-3234	Other Identifier	WHO
2018-004431-79	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CC-90001 400 mg once daily (QD)	Experimental	CC-90001 400 mg QD	Drug: CC-90001
CC-90001 200 mg once daily	Experimental	CC-90001 200 mg QD	Drug: CC-90001
CC-90001 100 mg once daily	Experimental	CC-90001 100 mg QD	Drug: CC-90001
Placebo once daily	Placebo Comparator	Placebo QD	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
CC-90001	Drug	oral	CC-90001 100 mg once daily CC-90001 200 mg once daily CC-90001 400 mg once daily (QD)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52	Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.	From baseline up to week 52

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52	Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) Stage 0 - None; Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; Stage 1c - Portal/periportal fibrosis only; Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; Stage 3 - Bridging fibrosis; Stage 4 - Cirrhosis.

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute		Phoenix	Arizona	85013	United States

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	CC-90001 100mg	CC-90001 100 mg PO QD
FG001	CC-90001 200mg	CC-90001 200 mg PO QD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 16, 2021

Arm/Group Information

ID	Title	Description
BG000	CC-90001 100mg	CC-90001 100 mg PO QD
BG001	CC-90001 200mg	CC-90001 200 mg PO QD
BG002	CC-90001 400mg	CC-90001 400 mg PO QD
BG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
BG004	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
	BG00052.2± 12.37 BG00158.3± 9.92 BG00252.1± 11.91 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG00111 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52

Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint.

The NASH CRN Histologic Scoring System comprised:

steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)

Stage 0 - None;
Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;
Stage 1c - Portal/periportal fibrosis only;
Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;
Stage 3 - Bridging fibrosis;
Stage 4 - Cirrhosis.

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants	OG00013 OG00115 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG00015.4(1.92 to 45.45) OG0010(0 to 21.80) OG0027.7(0.19 to 36.03) OG003

Secondary

Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52

Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint.

The NASH CRN Histologic Scoring System comprised:

steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)

Stage 0 - None;
Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;
Stage 1c - Portal/periportal fibrosis only;
Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis;
Stage 3 - Bridging fibrosis;
Stage 4 - Cirrhosis.

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg

Secondary

Percentage of Participants With Improvement in Total NAS

Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Secondary

Percentage of Participants With Resolution of NASH

Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52.

Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Secondary

Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis

Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52

Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Secondary

Percentage of Participants Who Progressed to Cirrhosis

Percentage of participants who progressed to cirrhosis

Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of Participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Mean Change From Baseline in Liver Biochemistry

Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)

Full Analysis Set Population at Week 52 with evaluable measures

Posted

Mean

Standard Deviation

U/L

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts

Secondary

Mean Change From Baseline in Metabolic Parameters

Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides

Full Analysis Set Population at Week 52 with evaluable measures

Posted

Mean

Standard Deviation

mmol/L

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Cmax

Cmax is defined as maximum plasma concentration of the drug

PK evaluable population

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Day 1 and at Week 4

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Tmax

Tmax is defined is the time to maximum plasma concentration

PK evaluable population

Posted

Median

Full Range

hours

Day 1 and at Week 4

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

AUC (0-t)

Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

PK evaluable population

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Day 1 and at Week 4

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

AUC t

Area under the plasma concentration time-curve. AUC over the dosing interval.

PK evaluable population

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Day 1 and at Week 4

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Apparent Total Body Clearance of the Drug

Apparent total body clearance of the drug (CL/F)

PK evaluable population

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

At Week 4

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Number of Participants With Treatment Related Safety Events

Number of participants with treatment related safety events

Safety Population

Posted

Number

participants

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Mean Change From Baseline of ECG Results - PR Intervals

Mean change from baseline in PR interval

PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)

Safety Population

Posted

Mean

Standard Deviation

msec

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Mean Change From Baseline of ECG Results - QRS Duration

Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)

Safety Population

Posted

Mean

Standard Deviation

msec

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Mean Change From Baseline of ECG Results - QT Interval

Mean change from baseline in QT interval

QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

Safety Population

Posted

Mean

Standard Deviation

msec

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Units	Counts
Participants

Secondary

Mean Change From Baseline of ECG Results - QTcB Interval

Mean change from baseline in QTcB interval

QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

QTc: QT interval corrected based on the patient's heart rate

QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate

Safety Population

Posted

Mean

Standard Deviation

msec

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Secondary

Mean Change From Baseline of ECG Results - QTcF Interval

Mean change from baseline in QTcF interval

QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec

QTc: QT interval corrected based on the patient's heart rate

QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate

Safety Population

Posted

Mean

Standard Deviation

msec

From baseline up to week 52

ID	Title	Description
OG000	CC-90001 100mg	CC-90001 100 mg PO QD
OG001	CC-90001 200mg	CC-90001 200 mg PO QD
OG002	CC-90001 400mg	CC-90001 400 mg PO QD
OG003	Placebo	Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CC-90001 100 mg	CC-90001 100 mg PO QD	13	2	13	10	13
EG001	CC-90001 200 mg	CC-90001 200 mg PO QD	15	1	15	13	15
EG002	CC-90001 400 mg	CC-90001 400 mg PO QD	13	2	13	12	13
EG003	Placebo	Placebo	15	0	15	10	15
EG004	Active Treatment Phase CC-90001 200 mg Following Placebo	CC-90001 200 mg PO QD	1	0	1	1	1
EG005	Active Treatment Phase CC-90001 400 mg Following Placebo	CC-90001 400 mg PO QD	1	0	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG0030 affected15 at risk EG0040 affected1 at risk EG0050 affected1 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Spinal retrolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Allergic eosinophilia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG0030 affected15 at risk EG0040 affected1 at risk EG0050 affected1 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0022 affected13 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected15 at risk EG0020 affected13 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0011 affected15 at risk EG0026 affected13 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected15 at risk EG0021 affected13 at risk EG003
Injection site pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0021 affected13 at risk EG003
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0024 affected13 at risk EG003
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Hordeolum	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Nail bed infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0021 affected13 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Liver function test increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Occult blood positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Urine cytology abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Weight increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0021 affected13 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0012 affected15 at risk EG0024 affected13 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected13 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0020 affected13 at risk EG003
Haematoma	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected13 at risk EG0010 affected15 at risk EG0021 affected13 at risk EG003

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008103	Liver Cirrhosis

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms