Study to Evaluate ARO-APOC3 in Adults With Severe Hypertr... | NCT04720534

Label	Type	Description	Intervention Names
Placebo, Day 1 and Week 12	Experimental	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.	Drug: Placebo
ARO-APOC3 10 mg	Experimental	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	Drug: ARO-APOC3
ARO-APOC3 25 mg	Experimental	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	Drug: ARO-APOC3
ARO-APOC3 50 mg	Experimental	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	Drug: ARO-APOC3

Name	Type	Description	Arm Group Labels	Other Names
ARO-APOC3	Drug	2 doses of ARO-APOC3 by subcutaneous (sc) injection	ARO-APOC3 10 mg ARO-APOC3 25 mg ARO-APOC3 50 mg

Measure	Description	Time Frame
Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)		Baseline, Week 24

Measure	Description	Time Frame
Percent Change From Baseline Over Time Through Week 48 in Fasting TG		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III		Baseline, Week 24

Facility	Status	City	State	ZIP	Country	Contacts
Research Site 2		Beverly Hills	California	90211	United States
Research Site 4

PubMed Identifier	Type	Citation	Retractions
38583092	Derived	Gaudet D, Pall D, Watts GF, Nicholls SJ, Rosenson RS, Modesto K, San Martin J, Hellawell J, Ballantyne CM. Plozasiran (ARO-APOC3) for Severe Hypertriglyceridemia: The SHASTA-2 Randomized Clinical Trial. JAMA Cardiol. 2024 Jul 1;9(7):620-630. doi: 10.1001/jamacardio.2024.0959.

ID	Title	Description
FG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
FG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 26, 2023	Mar 3, 2026

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

Percent Change From Baseline at Week 24 in Fasting Triglycerides (TG)

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Units	Counts
Participants	OG00059 OG00150 OG00254 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-17.2± 5.27 OG001-66.0± 5.61 OG002-70.2± 5.51 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed models repeated measures (MMRM)		< 0.0001	MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms. Observed cases of the data from baseline through Week 48 are included.	Difference	-48.8			2-Sided	95	-64.0	-33.7					Superiority
OG000

Secondary

Percent Change From Baseline Over Time Through Week 48 in Fasting TG

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline Over Time Through Week 48 in ApoC-III

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline Over Time Through Week 48 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Observed cases.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)

LDL-C analyses used both Martin-Hopkins methodology and ultracentrifugation. The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Participants with given assessment at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C

LDL-C analyses used both Martin-Hopkins methodology (MHM) and ultracentrifugation (UC). The Martin-Hopkins formula is a method for calculating LDL-C that improves accuracy by using an adjustable factor for estimating very-low-density lipoprotein (VLDL) cholesterol cholesterol based on triglyceride and non-HDL cholesterol levels.

Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP). Participants with given assessment at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Secondary

Change From Baseline in Plasma Concentrations of ARO-APOC3 Over TimeThrough Week 12

Full PK Analysis Set: Full Analysis Set (FAS) participants (all randomized participants who received at least 1 dose of IP during the study period) who had sufficient plasma concentration data at given time point to facilitate determination of PK parameters.

Posted

Mean

Standard Deviation

ng/mL

Day 1: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose

ID	Title	Description
OG000	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Units	Counts

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. TEAEs are AEs that occur following investigational product (IP) administration or a pre-existing condition exacerbated following IP administration.

Safety Analysis Set: All participants who receive at least 1 dose of IP.

Posted

Count of Participants

Participants

From first dose of study drug up to Week 48

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Post-Hoc

Ad Hoc Analysis: Percent Change From Baseline at Week 24 and Over Time Through Week 48 in ApoC-III

Full Analysis Set: All randomized participants who received at least 1 dose of investigational product (IP), excluding participants with values below the limit of quantification (BLQ) at Baseline, along with one site. Observed cases at given time point.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

ID	Title	Description
OG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
OG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
OG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG0031 affected56 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Testicular failure	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Vision blurred	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected61 at risk EG0013 affected54 at risk EG0021 affected55 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0021 affected55 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Vomiting projectile	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Influenza like illness	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Injection site erythema	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Injection site pruritus	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0012 affected54 at risk EG0021 affected55 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Vessel puncture site bruise	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0022 affected55 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Bacterial vulvovaginitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0014 affected54 at risk EG0020 affected55 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 affected61 at risk EG00111 affected54 at risk EG0029 affected55 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Coronavirus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Cystitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Ear infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Eye infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Fungal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hordeolum	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0011 affected54 at risk EG0022 affected55 at risk EG003
Joint injury	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Otitis media	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Periodontitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0013 affected54 at risk EG0024 affected55 at risk EG003
Skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Tooth infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 affected61 at risk EG0015 affected54 at risk EG0024 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0006 affected61 at risk EG0016 affected54 at risk EG0021 affected55 at risk EG003
Viral infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0013 affected54 at risk EG0021 affected55 at risk EG003
Graft complication	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Tooth injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Activated partial thromboplastin time abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Amylase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Anion gap increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0022 affected55 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Blood glucose increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0021 affected55 at risk EG003
Blood insulin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Blood testosterone decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
C-reactive protein increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Cardiac murmur	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Electrocardiogram change	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Globulins decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Glucose urine present	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0014 affected54 at risk EG0022 affected55 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hyperuricaemia	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Insulin C-peptide increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
International normalised ratio increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Lipase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Occult blood positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Platelet count increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Protein urine present	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Serum ferritin decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected61 at risk EG0014 affected54 at risk EG0021 affected55 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Hyperinsulinaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Latent autoimmune diabetes in adults	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected61 at risk EG0011 affected54 at risk EG0024 affected55 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected61 at risk EG0013 affected54 at risk EG0021 affected55 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0015 affected54 at risk EG0021 affected55 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0012 affected54 at risk EG0022 affected55 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Cervicogenic headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected61 at risk EG0018 affected54 at risk EG0026 affected55 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Migraine	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Sciatica	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0022 affected55 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Microalbuminuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0022 affected55 at risk EG003
Osteoarthritis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0021 affected55 at risk EG003
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0012 affected54 at risk EG0020 affected55 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0023 affected55 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Haematoma	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected61 at risk EG0010 affected54 at risk EG0022 affected55 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.
BG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
BG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
BG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo, Day 1 and Week 12	Participants received a total of 2 placebo SC injections on Day 1 and Week 12 for a total of 2 injections.	61	10	61	44	61
EG001	ARO-APOC3 10 mg	Participants received a total of 2 ARO-APOC3 10 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	54	4	54	44	54
EG002	ARO-APOC3 25 mg	Participants received a total of 2 ARO-APOC3 25 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	55	2	55	36	55
EG003	ARO-APOC3 50 mg	Participants received a total of 2 ARO-APOC3 50 mg SC injections on Day 1 and Week 12 for a total of 2 injections.	56	7	56	50	56

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG0030 affected56 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0021 affected55 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Breast cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0011 affected54 at risk EG0020 affected55 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected61 at risk EG0010 affected54 at risk EG0020 affected55 at risk EG003