An Extension Trial of Inclisiran in Participants With Car... | NCT03060577

ID	Type	Description	Link
2016-003815-37	EudraCT Number

Label	Type	Description	Intervention Names
Inclisiran-only	Experimental	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter for up to 4 years.	Drug: Inclisiran
Switching	Active Comparator	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter for up to 4 years.	Drug: Inclisiran Drug: Evolocumab

Name	Type	Description	Arm Group Labels	Other Names
Inclisiran	Drug	Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.

Measure	Description	Time Frame
Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm)	Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.	Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total)

Measure	Description	Time Frame
Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)	Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.	Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completion of Study MDCO-PCS-15-01 and no contraindication to receiving inclisiran or evolocumab.
Willing and able to give written and informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
Willing to self-inject.

Exclusion Criteria:

Any uncontrolled or serious disease, or any medical or surgical condition that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate's] judgment).
An underlying known disease or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate), might interfere with interpretation of the clinical study results.
Serious comorbid disease in which the life expectancy of the participant is shorter than the duration of the trial (for example, acute systemic infection, cancer, or other serious illnesses).
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation greater than 2 times upper limit of normal (ULN); or total bilirubin elevation greater than 1.5 times ULN at study entry visit.
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (for example, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion are
- Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age
- Postmenopausal women (as defined above) and less than 55 years old with a negative pregnancy test within 24 hours of enrollment
- Women who are surgically sterilized at least 3 months prior to enrollment
Males who are unwilling to use an acceptable method of birth control during the entire study period (that is, condom with spermicide).
Treatment with investigational medicinal products other than inclisiran or devices within 30 days or five half˗lives, whichever is longer.
Planned use of investigational medicinal products other than inclisiran or devices during the course of the study.
Participants with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients
Previous or current treatment (within 90 days of study entry) with monoclonal antibodies directed towards PCSK9.
Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
- Inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator.
- Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).
- Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (for example, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
- Involved with, or a relative of, someone directly involved in the conduct of the study.
- Any known cognitive impairment (for example, Alzheimer's Disease).

Name	Affiliation	Role
Kausik Ray, MD	Imperial College London	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Jacksonville	Florida	32216	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
36620965	Derived	Ray KK, Troquay RPT, Visseren FLJ, Leiter LA, Scott Wright R, Vikarunnessa S, Talloczy Z, Zang X, Maheux P, Lesogor A, Landmesser U. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023 Feb;11(2):109-119. doi: 10.1016/S2213-8587(22)00353-9. Epub 2023 Jan 5.
33990512

ID	Title	Description
FG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
FG001	Switching	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 7, 2020	Nov 28, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm)

Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants analyzed includes all participants in the Safety Analysis Set of the Inclisiran-only arm with evaluable data for the endpoint.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Day 210 (ORION-3) (up to 570 days total)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000277

Title

Denominators

Categories

Title	Measurements
	OG000-47.48(-50.69 to -44.27)

Secondary

Percentage Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)

Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Absolute Change in LDL-C From Baseline of the ORION-1 Study (Inclisiran Arm)

Absolute Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in LDL-C. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

mg/dL

Baseline (ORION-1) and Days 30, 360, 720, 1080 and 1440 (ORION-3) (up to 390, 720, 1080, 1440 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Percentage Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)

Percent Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Absolute Change in PCSK9 Levels From Baseline of the ORION-1 Study (Inclisiran Arm)

Absolute Change in PCSK9 from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in PCSK9. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

ug/L

Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)

Percent Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Triglycerides From Baseline of the ORION-1 Study (Inclisiran Arm)

Absolute Change in Triglycerides from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Triglycerides. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

mg/dL

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)

Percent Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Apolipoprotein B From Baseline of the ORION-1 Study (Inclisiran Arm)

Absolute Change in Apolipoprotein B from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Apolipoprotein B. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

mg/dL

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)

Percent Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative percentage score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

Percentage Change

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Lipoprotein-a From Baseline of the ORION-1 Study (Inclisiran Arm)

Absolute Change in Lipoprotein-a from baseline of the ORION-1 Study overtime in ORION-3. A negative score represents a reduction in Lipoprotein-a. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed per row represents participants in the Safety Analysis set of the Inclisiran-only arm with evaluable data at each time point.

Posted

Mean

95% Confidence Interval

nmol/L

Baseline (ORION-1) and Days 30, 210 and 1440 (ORION-3) (up to 390, 570 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Number of Participants With ≥50% LDL-C Reduction From Baseline of the ORION-1 Study (Inclisiran Arm)

Number of Participants with ≥50% LDL-C (beta-quantification) Reduction from baseline of the ORION-1 Study overtime in ORION-3. Changes are relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.

The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm. The number analyzed per row represents participants with evaluable data at each time point.

Posted

Count of Participants

Participants

Baseline (ORION-1) and Days 30, 360, 720 and 1440 (ORION-3) (up to 390, 720, 1080 and 1800 days total, respectively)

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL (Inclisiran Arm)

Individual responsiveness to inclisiran is defined as the number of Participants Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL at any time point.

The overall number of participants and the number analyzed includes all participants in the Safety Analysis set of the Inclisiran-only arm.

Posted

Count of Participants

Participants

From the start of treatment in ORION-3 to 90 days after end of treatment, assessed up to maximum duration of 4 years

ID	Title	Description
OG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Angina unstable	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bradycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Mitral valve disease	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Epiploic appendagitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ileus	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
General physical health deterioration	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Vascular stent restenosis	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Appendicitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bacterial infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
COVID-19	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diverticulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Escherichia sepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Infected bite	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Localised infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tooth abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Urosepsis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Anaesthetic complication cardiac	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pulse abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Glottis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hodgkin's disease stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Testicular seminoma (pure) stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cerebral infarction	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Encephalopathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nervous system disorder	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Presyncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Sciatica	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Syncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Delirium	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urethral perforation	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic aneurysm	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Circulatory collapse	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Giant cell arteritis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Hypertensive urgency	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Intermittent claudication	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0014 affected90 at risk EG0022 affected87 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
White blood cell disorder	Blood and lymphatic system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Angina pectoris	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00017 affected284 at risk EG0014 affected90 at risk EG0025 affected87 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Arrhythmia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Atrial flutter	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Bradycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Bundle branch block left	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bundle branch block right	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Coronary artery aneurysm	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dilatation atrial	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Extrasystoles	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Palpitations	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Pericardial effusion	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Right ventricular dilatation	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ear swelling	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Goitre	Endocrine disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypothyroidism	Endocrine disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Thyroid cyst	Endocrine disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Thyroid mass	Endocrine disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Blepharitis	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cataract	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Chalazion	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Corneal erosion	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dacryostenosis acquired	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diplopia	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dry eye	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Entropion	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Epiretinal membrane	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Eye swelling	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Glaucoma	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Iritis	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lacrimal mucocoele	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lacrimation decreased	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Macular degeneration	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Macular hole	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Meibomian gland dysfunction	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Meibomianitis	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Metamorphopsia	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ocular hyperaemia	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ocular hypertension	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Photophobia	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Retinal artery embolism	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Retinal haemorrhage	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Retinal vein occlusion	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Retinopathy hypertensive	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Vision blurred	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Visual impairment	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vitreous detachment	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vitreous floaters	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00013 affected284 at risk EG0014 affected90 at risk EG0023 affected87 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0013 affected90 at risk EG0022 affected87 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Buccal polyp	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0015 affected90 at risk EG0025 affected87 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dental caries	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00017 affected284 at risk EG0013 affected90 at risk EG0029 affected87 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0011 affected90 at risk EG0024 affected87 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Enteritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Flatulence	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Gastritis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastrointestinal scarring	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0012 affected90 at risk EG0025 affected87 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Levator syndrome	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Malpositioned teeth	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Melaena	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00018 affected284 at risk EG0013 affected90 at risk EG0026 affected87 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pancreatic steatosis	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Salivary gland disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Salivary gland enlargement	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Toothache	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Adverse drug reaction	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Asthenia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Chest discomfort	General disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Chills	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Complication of device insertion	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Crepitations	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cyst	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Discomfort	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Drug intolerance	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Face oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Fatigue	General disorders	MedDRA (18.1)	Systematic Assessment	EG00023 affected284 at risk EG0013 affected90 at risk EG00210 affected87 at risk
Feeling abnormal	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gait disturbance	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hernia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Influenza like illness	General disorders	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0012 affected90 at risk EG0023 affected87 at risk
Injection site bruising	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0014 affected90 at risk EG0023 affected87 at risk
Injection site discolouration	General disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Injection site erythema	General disorders	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Injection site haematoma	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Injection site haemorrhage	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Injection site oedema	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Injection site pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0010 affected90 at risk EG0024 affected87 at risk
Injection site paraesthesia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Injection site pruritus	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Injection site rash	General disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Injection site reaction	General disorders	MedDRA (18.1)	Systematic Assessment	EG00016 affected284 at risk EG0012 affected90 at risk EG0024 affected87 at risk
Injection site urticaria	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Injection site vesicles	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Injection site warmth	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Malaise	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Medical device complication	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nodule	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG00013 affected284 at risk EG0011 affected90 at risk EG0024 affected87 at risk
Oedema peripheral	General disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected284 at risk EG0012 affected90 at risk EG0026 affected87 at risk
Pain	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Peripheral swelling	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Polyp	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pyrexia	General disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Vessel puncture site bruise	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vessel puncture site induration	General disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Allergy to animal	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Food allergy	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Hypersensitivity	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Mite allergy	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rubber sensitivity	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Seasonal allergy	Immune system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0012 affected90 at risk EG0022 affected87 at risk
Abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abscess of eyelid	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acarodermatitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acute sinusitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bacterial infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bacteriuria	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Balanitis candida	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bronchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0013 affected90 at risk EG0024 affected87 at risk
COVID-19	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Candida infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Chlamydial infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Conjunctivitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Corneal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Coronavirus infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cystitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0012 affected90 at risk EG0026 affected87 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diverticulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0012 affected90 at risk EG0022 affected87 at risk
Ear infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0025 affected87 at risk
Ear lobe infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Erysipelas	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
External ear cellulitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Eye infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Folliculitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Fungal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Fungal skin infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Furuncle	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0012 affected90 at risk EG0022 affected87 at risk
Genital herpes simplex	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Genital infection fungal	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gingivitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Helicobacter infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Hepatitis C	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Herpes simplex	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Herpes zoster	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Hordeolum	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Impetigo	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Influenza	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00036 affected284 at risk EG0016 affected90 at risk EG00210 affected87 at risk
Kidney infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Klebsiella infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Labyrinthitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Localised infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00011 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Mastitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nail infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00055 affected284 at risk EG0016 affected90 at risk EG00213 affected87 at risk
Onychomycosis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oral candidiasis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oral fungal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oral herpes	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Oral infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Orchitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Otitis externa	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Otitis media	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Paronychia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Perichondritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Pharyngitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Pneumonia	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Pneumonia viral	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Postoperative wound infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulpitis dental	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rash pustular	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Retinitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Rhinitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Root canal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sebaceous gland infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinusitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0013 affected90 at risk EG0023 affected87 at risk
Skin infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Staphylococcal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Suspected COVID-19	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tinea cruris	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Tooth abscess	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Tooth infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00024 affected284 at risk EG0011 affected90 at risk EG0025 affected87 at risk
Urethritis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG00037 affected284 at risk EG0016 affected90 at risk EG0027 affected87 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vaginal infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Viral diarrhoea	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Viral infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Wound infection	Infections and infestations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0013 affected90 at risk EG0020 affected87 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0012 affected90 at risk EG0023 affected87 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG00024 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0013 affected90 at risk EG0021 affected87 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Musculoskeletal injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Product dispensing error	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Reactive gastropathy	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Traumatic shock	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ulnar nerve injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Wrong dose	Injury, poisoning and procedural complications	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood bilirubin increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood calcium increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Blood creatinine increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Blood folate decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood glucose abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood glucose increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Blood potassium decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Blood potassium increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood pressure increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Blood sodium decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood urea increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood uric acid decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blood uric acid increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Blood urine present	Investigations	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Body temperature increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
C-reactive protein increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Carbohydrate antigen 19-9 increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Carcinoembryonic antigen increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cardiac murmur	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Carotid bruit	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Electrocardiogram abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Haematocrit decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Haemoglobin decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Heart rate decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Heart rate irregular	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0009 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
International normalised ratio increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Intraocular pressure increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Lipoprotein (a) increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lipoprotein increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Liver function test abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Liver function test increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Low density lipoprotein increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Mean cell volume increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Neutrophil count increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Platelet count decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Platelet count increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Prostatic specific antigen increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulmonary function test decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pulse absent	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
QRS axis abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
SARS-CoV-2 test positive	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinus rhythm	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spirometry abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Streptococcus test positive	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Thyroid function test abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Troponin T increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urine analysis abnormal	Investigations	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vitamin B12 decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vitamin D decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Weight decreased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Weight increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
White blood cell count increased	Investigations	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG00032 affected284 at risk EG0010 affected90 at risk EG0026 affected87 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0010 affected90 at risk EG0026 affected87 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0011 affected90 at risk EG0025 affected87 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00040 affected284 at risk EG00110 affected90 at risk EG00210 affected87 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Axillary mass	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00028 affected284 at risk EG0011 affected90 at risk EG00213 affected87 at risk
Bone atrophy	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Enthesopathy	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Exostosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Femoroacetabular impingement	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Finger deformity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Loose body in joint	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00015 affected284 at risk EG0016 affected90 at risk EG0022 affected87 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00024 affected284 at risk EG0017 affected90 at risk EG0023 affected87 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00016 affected284 at risk EG0012 affected90 at risk EG0026 affected87 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00025 affected284 at risk EG0011 affected90 at risk EG0026 affected87 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Shoulder deformity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0024 affected87 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG00011 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Blepharal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oral papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ageusia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Amnesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Anosmia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Balance disorder	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Burning sensation	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cerebral infarction	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cluster headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cognitive disorder	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Disturbance in attention	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG00024 affected284 at risk EG0014 affected90 at risk EG0025 affected87 at risk
Dizziness postural	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dysarthria	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Epilepsy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Head discomfort	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Headache	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG00021 affected284 at risk EG0018 affected90 at risk EG0027 affected87 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0012 affected90 at risk EG0022 affected87 at risk
Loss of consciousness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Memory impairment	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Migraine	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Migraine with aura	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Muscle tension dysphonia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Nerve compression	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Nervous system disorder	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Occipital neuralgia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Ophthalmic migraine	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Paraesthesia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Parkinson's disease	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Parkinsonism	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Piriformis syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Polyneuropathy	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Presyncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Sciatica	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Sensory loss	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Somnolence	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Syncope	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Taste disorder	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Tremor	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Vascular dementia	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Device dislocation	Product Issues	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Prosthetic cardiac valve failure	Product Issues	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acute stress disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Agitation	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Alcoholism	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Anxiety	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Burnout syndrome	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Confusional state	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Delirium	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Depressed mood	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Depression	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG00012 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Disorientation	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Emotional disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Emotional distress	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Fear	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Indifference	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Insomnia	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Nightmare	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Panic attack	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Seasonal affective disorder	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Stress	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Albuminuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Bladder cyst	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dysuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Glycosuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0009 affected284 at risk EG0011 affected90 at risk EG0023 affected87 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Incontinence	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Leukocyturia	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Micturition disorder	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Myoglobinuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nephropathy	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nocturia	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Polyuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Proteinuria	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Renal colic	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Renal cyst	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Renal failure	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Renal impairment	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Ureteral disorder	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Urinary tract discomfort	Renal and urinary disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0010 affected90 at risk EG0023 affected87 at risk
Breast disorder female	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Breast pain	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Genital rash	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Penile erythema	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Spermatocele	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Vaginal dysplasia	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vulvovaginal pain	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0011 affected90 at risk EG0024 affected87 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0007 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00022 affected284 at risk EG0011 affected90 at risk EG0025 affected87 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00022 affected284 at risk EG0012 affected90 at risk EG0025 affected87 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0010 affected90 at risk EG0025 affected87 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0008 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pulmonary calcification	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0012 affected90 at risk EG0020 affected87 at risk
Sinonasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Upper respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Actinic elastosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0011 affected90 at risk EG0022 affected87 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0012 affected90 at risk EG0022 affected87 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0004 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Keloid scar	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Precancerous skin lesion	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected284 at risk EG0012 affected90 at risk EG0023 affected87 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0005 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00011 affected284 at risk EG0012 affected90 at risk EG0021 affected87 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0021 affected87 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Skin depigmentation	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Skin induration	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Xanthoma	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Abortion induced	Surgical and medical procedures	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic aneurysm	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0022 affected87 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic dilatation	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Circulatory collapse	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Extremity necrosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Flushing	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0011 affected90 at risk EG0020 affected87 at risk
Hot flush	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypertension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG00042 affected284 at risk EG0012 affected90 at risk EG00217 affected87 at risk
Hypertensive crisis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Hypertensive urgency	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Hypotension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0006 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Intermittent claudication	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Lymphoedema	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0003 affected284 at risk EG0010 affected90 at risk EG0021 affected87 at risk
Peripheral coldness	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Peripheral venous disease	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0002 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Post thrombotic syndrome	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Thrombosis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Varicophlebitis	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk
Varicose vein	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 affected284 at risk EG0010 affected90 at risk EG0020 affected87 at risk

ID	Term
D050197	Atherosclerosis
D006938	Hyperlipoproteinemia Type II

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006951	Hyperlipoproteinemias
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	Inclisiran-only	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.
BG001	Switching	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336. Then, participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.
BG002	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	Inclisiran Only Arm	Participants received subcutaneous injections of inclisiran 300 milligrams (mg) on Day 1 and every 180 days thereafter up to Year 4.	7	284	104	284	271	284
EG001	Switching Arm up to Day 360 Visit	Participants received self-administered subcutaneous injections of evolocumab 140 mg on Day 1 and every 14 days thereafter until Day 336.	0	90	16	90	78	90
EG002	Switching Arm After Day 360 Visit	Participants received subcutaneous injections of inclisiran 300 mg on Day 360 and every 180 days thereafter up to Year 4.	1	87	30	87	77	87