Study of NGM282 in Patients With Nonalcoholic Steatohepat... | NCT02443116

Name	Class
NGM Biopharmaceuticals Australia Pty Ltd	INDUSTRY

Label	Type	Description	Intervention Names
Cohort 1 - Placebo	Placebo Comparator	Cohort 1 - Placebo	Other: Placebo
Cohort 1 - NGM282 3mg	Experimental	Cohort 1 - NGM282 3mg	Biological: NGM282
Cohort 1 - NGM282 6mg	Experimental	Cohort 1 - NGM282 6mg	Biological: NGM282
Cohort 2 - NGM282 0.3mg	Experimental	Cohort 2 - NGM282 0.3mg	Biological: NGM282
Cohort 2 - NGM282 1mg	Placebo Comparator	Cohort 2 - NGM282 1mg	Biological: NGM282
Cohort 2 - NGM282 3mg	Experimental	Cohort 2 - NGM282 3mg	Biological: NGM282
Cohort 3 - NGM282 1mg

Name	Type	Description	Arm Group Labels	Other Names
NGM282	Biological		Cohort 1 - NGM282 3mg Cohort 1 - NGM282 6mg Cohort 2 - NGM282 0.3mg Cohort 2 - NGM282 1mg Cohort 2 - NGM282 3mg Cohort 3 - NGM282 1mg

Measure	Description	Time Frame
Change in Absolute Liver Fat Content (Part 1)	Absolute liver fat content was assessed using magnetic resonance imaging (MRI).	Up to Week 12
Change in Absolute Liver Fat Content (Part 2)	Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).	Up to Week 12
Change in Absolute Liver Fat Content (Part 3)	Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).	Up to Week 24

Measure	Description	Time Frame
Percentage Change in Liver Fat Content (Part 1)	Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).	Up to Week 12
Change in Absolute Liver Fat Content (Part 2)

Name	Affiliation	Role
NGM Study Director	NGM Biopharmaceuticals, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
NGM Clinical Study Site 922		Chandler	Arizona	85224	United States
NGM Clinical Study Site 923

PubMed Identifier	Type	Citation	Retractions
39326675	Derived	Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
36318027	Derived

ID	Title	Description
FG000	Part 1: Aldafermin 3.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 29, 2019	Mar 11, 2025

Arm/Group Information

ID	Title	Description
BG000	Part 1: Aldafermin 3.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG001	Part 1: Aldafermin 6.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG002	Part 1: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG003	Part 2: Aldafermin 0.3 mg	Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG004	Part 2: Aldafermin 1.0 mg	Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG005	Part 2: Aldafermin 3.0 mg	Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG006	Part 2: Aldafermin 1.0 mg (Cohort 4)	Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
BG007	Part 3: Aldafermin 1.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home.
BG008	Part 3: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 6, 8, 12, 18, and 24 were self-administered in the clinic, with all other doses throughout the treatment period self-administered at home.
BG009	Total	Total of all reporting groups

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

Change in Absolute Liver Fat Content (Part 1)

Absolute liver fat content was assessed using magnetic resonance imaging (MRI).

Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percent of liver fat

Up to Week 12

ID	Title	Description
OG000	Part 1: Aldafermin 3.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 1: Aldafermin 6.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG002	Part 1: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Units	Counts
Participants	OG00027 OG00128 OG00227

Title

Denominators

Categories

Title	Measurements
	OG000-9.68± 0.98 OG001-11.91± 1.00 OG002-0.85± 0.99

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 OG002	The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.	t-test, 2 sided		<0.001	p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.	Difference in least squares means	-8.84	Standard Error of the Mean	1.37	2-Sided	96	-12.09	-5.59					Superiority

Primary

Change in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percent of liver fat

Up to Week 12

ID	Title	Description
OG000	Part 2: Aldafermin 0.3 mg	Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 2: Aldafermin 1.0 mg	Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG002	Part 2: Aldafermin 3.0 mg	Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Primary

Change in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percent of liver fat

Up to Week 24

ID	Title	Description
OG000	Part 3: Aldafermin 1.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 3: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Units	Counts
Participants

Secondary

Percentage Change in Liver Fat Content (Part 1)

Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).

Percentage change in liver fat content was assessed in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percentage change of liver fat content

Up to Week 12

ID	Title	Description
OG000	Part 1: Aldafermin 3.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 1: Aldafermin 6.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG002	Part 1: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Secondary

Change in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Absolute liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percent of liver fat

Up to Week 18

ID	Title	Description
OG000	Part 2: Aldafermin 0.3 mg	Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 2: Aldafermin 1.0 mg	Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG002	Part 2: Aldafermin 3.0 mg	Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Secondary

Percentage Change in Liver Fat Content (Part 2)

Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percentage change of liver fat content

Up to Week 18

ID	Title	Description
OG000	Part 2: Aldafermin 0.3 mg	Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 2: Aldafermin 1.0 mg	Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG002	Part 2: Aldafermin 3.0 mg	Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Secondary

Change in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Absolute liver fat content was assessed in the Efficacy Population in participants with available data.

Posted

Least Squares Mean

Standard Error

percent of liver fat

Up to Week 30

ID	Title	Description
OG000	Part 3: Aldafermin 1.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 3: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Units	Counts
Participants

Secondary

Percentage Change in Liver Fat Content (Part 3)

Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population.

Posted

Least Squares Mean

Standard Error

percentage change of liver fat content

Up to Week 30

ID	Title	Description
OG000	Part 3: Aldafermin 1.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.
OG001	Part 3: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: Aldafermin 3.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	27	1	27	26	27
EG001	Part 1: Aldafermin 6.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 6.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	28	0	28	27	28
EG002	Part 1: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	27	0	27	23	27
EG003	Part 2: Aldafermin 0.3 mg	Participants who received a single subcutaneous injection of aldafermin 0.3 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	23	0	23	20	23
EG004	Part 2: Aldafermin 1.0 mg	Participants who received a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	21	1	21	19	21
EG005	Part 2: Aldafermin 3.0 mg	Participants who received a single subcutaneous injection of aldafermin 3.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	22	4	22	21	22
EG006	Part 2: Aldafermin 1.0 mg (Cohort 4)	Participants who received a single subcutaneous injection of aldafermin 1.0 mg (Cohort 4). The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	28	1	28	27	28
EG007	Part 3: Aldafermin 1.0 mg	Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	53	2	53	46	53
EG008	Part 3: Placebo	Participants who were randomized to receive a single subcutaneous injection of placebo. The first dose (Day 1) and doses at Weeks 1, 2, 4, 8, and 12 were self-administered in the clinic, with all other doses through Week 12 self-administered at home.	25	3	25	22	25

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute pancreatitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG0030 affected23 at risk EG0040 affected21 at risk EG0050 affected22 at risk EG0060 affected28 at risk EG0070 affected53 at risk EG0080 affected25 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Appendicitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Loose stools	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0007 affected27 at risk EG0015 affected28 at risk EG0022 affected27 at risk EG0031 affected23 at risk EG0043 affected21 at risk EG0055 affected22 at risk EG0066 affected28 at risk EG0070 affected53 at risk EG0080 affected25 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0008 affected27 at risk EG0013 affected28 at risk EG0021 affected27 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0013 affected28 at risk EG0024 affected27 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0015 affected28 at risk EG0020 affected27 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected27 at risk EG0013 affected28 at risk EG0020 affected27 at risk EG003
Bloating	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0014 affected28 at risk EG0020 affected27 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected27 at risk EG0011 affected28 at risk EG0021 affected27 at risk EG003
Nausea aggravated	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Abdominal bloating	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Diarrhea aggravated	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Hemorrhoids	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
RUQ pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Soft stools	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
GERD	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Increased frequency of defecation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Stomach cramps	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Injection site erythema	General disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected27 at risk EG00111 affected28 at risk EG0022 affected27 at risk EG003
Injection site reaction	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected27 at risk EG0014 affected28 at risk EG0020 affected27 at risk EG003
Injection site bruising	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0023 affected27 at risk EG003
Injection site pruritus	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0013 affected28 at risk EG0020 affected27 at risk EG003
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0022 affected27 at risk EG003
Injection site pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0021 affected27 at risk EG003
Injection site swelling	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected27 at risk EG0015 affected28 at risk EG0025 affected27 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0022 affected27 at risk EG003
Dizziness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk EG0020 affected27 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk EG0022 affected27 at risk EG003
Sinusitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0011 affected28 at risk EG0021 affected27 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0022 affected27 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0014 affected28 at risk EG0020 affected27 at risk EG003
Weight decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0013 affected28 at risk EG0020 affected27 at risk EG003
Blood creatinine increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Weight increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0022 affected27 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003
Abdominal cramp	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0020 affected27 at risk EG003
Emesis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Stool discoloration	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0020 affected27 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Blood cholesterol increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Glycosylated hemoglobin increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Influenza	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0020 affected27 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0011 affected28 at risk EG0021 affected27 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk EG0020 affected27 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0021 affected27 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Oedema peripheral	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Influenza like illness	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0010 affected28 at risk EG0020 affected27 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected27 at risk EG0011 affected28 at risk EG0021 affected27 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected27 at risk EG0012 affected28 at risk EG0020 affected27 at risk EG003

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases