Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dysl... | NCT04998201

ID	Type	Description	Link
2021-000688-57	EudraCT Number

Label	Type	Description	Intervention Names
ARO-APOC3 10 mg Q12W	Experimental	ARO-APOC3 10 milligrams (mg) subcutaneous (SC) injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	Drug: ARO-APOC3
ARO-APOC3 25 mg Q12W	Experimental	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	Drug: ARO-APOC3
ARO-APOC3 50 mg Q12W	Experimental	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	Drug: ARO-APOC3
ARO-APOC3 50 mg Q24W	Experimental	ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections	Drug: ARO-APOC3
Placebo	Placebo Comparator	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ARO-APOC3	Drug	ARO-APOC3 Injection	ARO-APOC3 10 mg Q12W ARO-APOC3 25 mg Q12W ARO-APOC3 50 mg Q12W ARO-APOC3 50 mg Q24W

Measure	Description	Time Frame
Percent Change From Baseline at Week 24 in Fasting TG	Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.	Baseline, Week 24

Measure	Description	Time Frame
Percent Change From Baseline Over Time Through Week 48 in Fasting TG	LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.	Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)

Facility	Status	City	State	ZIP	Country	Contacts
Research Site 3		Beverly Hills	California	90211	United States
Research Site 8

PubMed Identifier	Type	Citation	Retractions
38804517	Derived	Ballantyne CM, Vasas S, Azizad M, Clifton P, Rosenson RS, Chang T, Melquist S, Zhou R, Mushin M, Leeper NJ, Hellawell J, Gaudet D. Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):899-912. doi: 10.1056/NEJMoa2404143. Epub 2024 May 28.

ID	Title	Description
FG000	Placebo	Volume-matched placebo subcutaneous (SC) injection on Day 1 and Week 12 for a total of 2 injections
FG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 milligrams (mg) SC injection on Day 1 and Week 12 (Q12W) 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	Feb 6, 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 TG

Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG004	ARO-APOC3 50 mg Q24W	ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections

Units	Counts
Participants	OG00081 OG00161 OG00263 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-1.7± 3.07 OG001-51.5± 3.54 OG002-57.7± 3.49 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 Analysis		<0.0001	MMRM model included treatment arm, study visit, and baseline value as model terms. The model also included treatment by visit and treatment by baseline as interaction terms.	LS Mean Difference	-49.8			2-Sided	95	-59.0	-40.6					Superiority
OG000 OG002

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.

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	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Full Analysis Set: All randomized participants who receive at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections

Secondary

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

LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.

Posted

Least Squares Mean

Standard Error

percentage change

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG003	ARO-APOC3 50 mg Q12W

Secondary

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

An adverse event (AE) was any untoward medical occurrence, which did not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) was an AE that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or was a medically important event or reaction. TEAEs were AEs that occurred following study drug administration or a pre-existing condition exacerbated following study drug administration.

Safety Analysis Set: All participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Up to Week 48

ID	Title	Description
OG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
OG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
OG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG0030 affected66 at risk EG004
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Artery dissection	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Coeliac artery aneurysm	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Septic shock	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG0030 affected66 at risk EG004
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blepharal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment		EG0003 affected87 at risk EG0012 affected67 at risk EG0022 affected67 at risk EG003
Blood pressure inadequately controlled	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Haematoma	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hot flush	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0022 affected67 at risk EG003
Injection site erythema	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Chest discomfort	General disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Influenza like illness	General disorders	MedDRA 23.1	Systematic Assessment		EG0003 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Oedema	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Peripheral swelling	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Swelling face	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dystrophic calcification	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Injection site reaction	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Secretion discharge	General disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Sensation of foreign body	General disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Food allergy	Immune system disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Postmenopause	Social circumstances	MedDRA 23.1	Systematic Assessment	This is a sex-specific AE. Only female participants were at risk.	EG0000 affected41 at risk EG0011 affected31 at risk EG0020 affected30 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	This is a sex-specific AE. Only male participants were at risk.	EG0000 affected46 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	This is a sex-specific AE. Only male participants were at risk.	EG0001 affected46 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	This is a sex-specific AE. Only male participants were at risk.	EG0000 affected46 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0022 affected67 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acquired diaphragmatic eventration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blood urine present	Investigations	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0012 affected67 at risk EG0021 affected67 at risk EG003
Amylase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0023 affected67 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Blood pressure increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Blood urea increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Lipase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0023 affected67 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Troponin increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Anion gap increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0021 affected67 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0020 affected67 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Blood glucose increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blood insulin increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0003 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blood iron decreased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Blood uric acid increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0022 affected67 at risk EG003
C-reactive protein increased	Investigations	MedDRA 24.0	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Cardiac murmur	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Cells in urine	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Electrocardiogram T wave inversion	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Haematocrit increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Human metapneumovirus test positive	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Insulin C-peptide increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
International normalised ratio increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Laboratory test abnormal	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Neutrophil percentage increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Platelet count decreased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Platelet count increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA 23.1	Systematic Assessment	This is a sex-specific AE. Only male participants were at risk.	EG0000 affected46 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
White blood cell count increased	Investigations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0012 affected67 at risk EG0020 affected67 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0012 affected67 at risk EG0021 affected67 at risk EG003
Dental restoration failure	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Eye contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Eye injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Eyelid injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0023 affected67 at risk EG003
Lisfranc fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0020 affected67 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Skin wound	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Left atrial enlargement	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment		EG0003 affected87 at risk EG0012 affected67 at risk EG0023 affected67 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Complex regional pain syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Cubital tunnel syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Occipital neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Sciatica	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Cerebral artery stenosis	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0003 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Migraine	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Cataract	Eye disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dermatochalasis	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Myopia	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dry eye	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Eye pain	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Presbyopia	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Visual impairment	Eye disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Malabsorption	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0003 affected87 at risk EG0013 affected67 at risk EG0020 affected67 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0020 affected67 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Non-alcoholic fatty liver	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Sebaceous hyperplasia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0003 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment		EG0003 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0012 affected67 at risk EG0021 affected67 at risk EG003
Diffuse idiopathic skeletal hyperostosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0012 affected67 at risk EG0022 affected67 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Mixed connective tissue disease	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Nodal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0007 affected87 at risk EG0013 affected67 at risk EG0027 affected67 at risk EG003
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG00012 affected87 at risk EG0018 affected67 at risk EG00211 affected67 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0014 affected67 at risk EG0022 affected67 at risk EG003
Cystitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0014 affected67 at risk EG0022 affected67 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0010 affected67 at risk EG0022 affected67 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0007 affected87 at risk EG0014 affected67 at risk EG0026 affected67 at risk EG003
Abscess neck	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Ear infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hordeolum	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Rhinitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Abscess oral	Infections and infestations	MedDRA 24.0	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Bacteriuria	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Body tinea	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Dermatophytosis of nail	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0012 affected67 at risk EG0020 affected67 at risk EG003
Laryngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Localised infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0002 affected87 at risk EG0012 affected67 at risk EG0021 affected67 at risk EG003
Otitis media	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Paronychia	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0004 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Post-acute COVID-19 syndrome	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Pyuria	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Tinea versicolour	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Tooth infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0021 affected67 at risk EG003
Viral infection	Infections and infestations	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0021 affected67 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment		EG0004 affected87 at risk EG0015 affected67 at risk EG0024 affected67 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0022 affected67 at risk EG003
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0011 affected67 at risk EG0020 affected67 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0001 affected87 at risk EG0010 affected67 at risk EG0020 affected67 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment		EG0000 affected87 at risk EG0012 affected67 at risk EG0022 affected67 at risk EG003

ID	Title	Description
BG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections
BG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
BG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
BG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections
BG004	ARO-APOC3 50 mg Q24W	ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Volume-matched placebo SC injection on Day 1 and Week 12 for a total of 2 injections	0	87	5	87	55	87
EG001	ARO-APOC3 10 mg Q12W	ARO-APOC3 10 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	0	67	2	67	47	67
EG002	ARO-APOC3 25 mg Q12W	ARO-APOC3 25 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	1	67	5	67	44	67
EG003	ARO-APOC3 50 mg Q12W	ARO-APOC3 50 mg SC injection on Day 1 and Week 12 (Q12W) for a total of 2 injections	2	66	7	66	48	66
EG004	ARO-APOC3 50 mg Q24W	ARO-APOC3 50 mg SC injection on Day 1 and Week 24 (Q24W) for a total of 2 injections	1	66	5	66	48	66