Study of Aldafermin (NGM282) in Subjects With Compensated... | NCT04210245

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
Daily 0.3 mg dose	Experimental	Administered by subcutaneous injection	Biological: aldafermin
Daily 1 mg dose	Experimental	Administered by subcutaneous injection	Biological: aldafermin
Daily 3 mg dose	Experimental	Administered by subcutaneous injection	Biological: aldafermin
Placebo	Placebo Comparator	Administered by subcutaneous injection	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
aldafermin	Biological	aldafermin	Daily 0.3 mg dose Daily 1 mg dose Daily 3 mg dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.	48 weeks

Eligibility Module

Name	Affiliation	Role
NGM Study Director	NGM Biopharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
NGM Clinical Study Site		Glendale	Arizona	85306	United States
NGM Clinical Study Site 413

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37732990	Derived	Rinella ME, Lieu HD, Kowdley KV, Goodman ZD, Alkhouri N, Lawitz E, Ratziu V, Abdelmalek MF, Wong VW, Younes ZH, Sheikh AM, Brannan D, Freilich B, Membreno F, Sinclair M, Melchor-Khan L, Sanyal AJ, Ling L, Harrison SA. A randomized, double-blind, placebo-controlled trial of aldafermin in patients with NASH and compensated cirrhosis. Hepatology. 2024 Mar 1;79(3):674-689. doi: 10.1097/HEP.0000000000000607. Epub 2023 Sep 21.

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Daily 0.3 mg Dose	Administered by subcutaneous injection daily for 48 weeks
FG001	Daily 1 mg Dose	Administered by subcutaneous injection daily for 48 weeks

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	Yes	No	No	Study Protocol	Nov 11, 2021	Nov 14, 2024

Arm/Group Information

ID	Title	Description
BG000	Daily 0.3 mg Dose	Administered by subcutaneous injection daily for 48 weeks
BG001	Daily 1 mg Dose	Administered by subcutaneous injection daily for 48 weeks
BG002	Daily 3 mg Dose	Administered by subcutaneous injection daily for 48 weeks
BG003	Placebo	Administered by subcutaneous injection daily for 48 weeks
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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.7± 6.78 BG00161.3± 7.57 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG00123 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0018 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Height

centimeter

Mean

Standard Deviation

centimeter

Title

Denominators

Categories

Title	Measurements
	BG000164.3± 11.35 BG001167.5± 11.23 BG002

Weight

kilogram

Mean

Standard Deviation

kilogram

Title

Denominators

Categories

Title	Measurements
	BG00088.19± 9.680 BG001101.47± 22.240 BG002

BMI

kg/m^2

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00032.768± 3.2236 BG00135.979± 6.3231 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

Change From Baseline in Enhanced Liver Fibrosis Score at Week 48

Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.

ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.

Enrollment to the 0.3 mg dose treatment arm was terminated during the study.

Posted

Mean

Standard Deviation

score on a scale

48 weeks

ID	Title	Description
OG000	Daily 0.3 mg Dose	Administered by subcutaneous injection daily for 48 weeks.
OG001	Daily 1 mg Dose	Administered by subcutaneous injection daily for 48 weeks
OG002	Daily 3 mg Dose	Administered by subcutaneous injection daily for 48 weeks
OG003	Placebo	Administered by subcutaneous injection daily for 48 weeks

Units	Counts
Participants	OG0007 OG00137 OG00244 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.071± 0.7214 OG0010.125± 0.6938 OG002-0.213± 0.6145 OG003

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Daily 0.3 mg Dose	Administered by subcutaneous injection daily for 48 weeks	0	7	0	7	5	7
EG001	Daily 1 mg Dose	Administered by subcutaneous injection daily for 48 weeks	1	42	11	42	40	42
EG002	Daily 3 mg Dose	Administered by subcutaneous injection daily for 48 weeks	0	55	5	55	52	55
EG003	Placebo	Administered by subcutaneous injection daily for 48 weeks	0	56	3	56	49	56

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
COVID-19	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG0030 events0 affected56 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Femur fracture	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Cardiac failure acute	Cardiac disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Acute kidney disorders	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Lower respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Pyelonephritis acute	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Soft tissue infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG0030 events0 affected56 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0024 events4 affected55 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0016 events6 affected42 at risk EG0027 events7 affected55 at risk EG003
Injection site bruising	General disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0024 events4 affected55 at risk EG003
Injection site pain	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0023 events3 affected55 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0021 events1 affected55 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0020 events0 affected55 at risk EG003
Injection site erythema	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0025 events5 affected55 at risk EG003
Injection site pruritus	General disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0023 events3 affected55 at risk EG003
Reaction to food additive	Immune system disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0015 events5 affected42 at risk EG0022 events2 affected55 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected55 at risk EG003
Blood calcium increased	Investigations	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
White blood cell count increased	Investigations	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0023 events3 affected55 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0022 events2 affected55 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0024 events4 affected55 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0023 events3 affected55 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0028 events8 affected55 at risk EG003
Loss of consciousness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Memory impairment	Nervous system disorders	Systematic Assessment	EG0000 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0013 events3 affected42 at risk EG0026 events6 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0026 events6 affected55 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0022 events2 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0027 events7 affected55 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0015 events5 affected42 at risk EG0028 events8 affected55 at risk EG003
Diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Faeces discoloured	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0023 events3 affected55 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0023 events3 affected55 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0022 events2 affected55 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected7 at risk EG00112 events12 affected42 at risk EG00218 events18 affected55 at risk EG003
Varices oesophageal	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0025 events5 affected55 at risk EG003
Portal hypertension	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0026 events6 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0025 events5 affected55 at risk EG003
Dysuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0013 events3 affected42 at risk EG0021 events1 affected55 at risk EG003
Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0024 events4 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events5 affected42 at risk EG0027 events7 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events2 affected42 at risk EG0022 events2 affected55 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0022 events2 affected55 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0023 events3 affected55 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0022 events2 affected55 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected55 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0023 events3 affected55 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG00114 events14 affected42 at risk EG00213 events13 affected55 at risk EG003
Lower respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0022 events2 affected55 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0023 events3 affected55 at risk EG003
skin bacterial infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0022 events2 affected55 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected7 at risk EG0014 events4 affected42 at risk EG0024 events4 affected55 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected55 at risk EG003
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0022 events2 affected55 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0021 events1 affected55 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0023 events3 affected55 at risk EG003
Increased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0028 events8 affected55 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected55 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected7 at risk EG00111 events11 affected42 at risk EG00222 events22 affected55 at risk EG003

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