Inclisiran for Participants With Atherosclerotic Cardiova... | NCT03399370

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inclisiran	Experimental	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.	Drug: Inclisiran Sodium
Saline Solution	Placebo Comparator	Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Inclisiran Sodium	Drug	Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Inclisiran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage Change in LDL-C From Baseline to Day 510		Baseline, Day 510
Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540	Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported	Baseline, Day 90 to Day 540

Secondary Outcomes

Measure	Description	Time Frame
Absolute Change in LDL-C From Baseline to Day 510		Baseline, Day 510
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540	Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants ≥18 years of age.
History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
Participants on statins should be receiving a maximally tolerated dose.
Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

Exclusion Criteria:

New York Heart Association (NYHA) class IV heart failure.
Uncontrolled cardiac arrhythmia
Uncontrolled severe hypertension
Active liver disease
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
3. 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 (such as condom with spermicide).
Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Name	Affiliation	Role
Scott Wright, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site 10001-015		Birmingham	Alabama	35211	United States
Research Site 10001-138

PubMed Identifier	Type	Citation	Retractions
41604274	Derived	Landmesser U, Ray KK, Raal FJ, Garcia Conde L, Han J, Koenig W, Leiter LA, Schwartz GG, Wright RS; on behalf of the ORION Investigators. Inclisiran in Patients with CKD: Post Hoc Pooled Analysis of Three Phase 3 Trials. J Am Soc Nephrol. 2026 Jul 1;37(7):1497-1506. doi: 10.1681/ASN.0000001006. Epub 2026 Jan 28.
38757725	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months. Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
FG001	Saline Solution

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 31, 2019	Jul 1, 2020

Arm/Group Information

ID	Title	Description
BG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months. Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
BG001	Placebo	Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months. Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00066.4± 8.90 BG00165.7± 8.89 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000246 BG001232 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0014 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000781 BG001780 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage Change in LDL-C From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months. Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000781 OG001780

Title

Denominators

Categories

Title	Measurements
	OG000-56.34(-58.35 to -54.34) OG0011.30(-1.24 to 3.83)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<.0001	The a priori threshold for statistical significance was <0.05	Mean Difference (Final Values)	-57.64			2-Sided	95	-60.86	-54.43			Represents the least squares mean difference from Placebo		Superiority	LS Mean Difference (95% CI) from Placebo

Primary

Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540

Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 90 to Day 540

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Absolute Change in LDL-C From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540

Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Day 90 to Day 540

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Total Cholesterol From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Secondary

Percentage Change in Non-HDL-C From Baseline to Day 510

Intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Day 510

ID	Title	Description
OG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
OG001	Placebo	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inclisiran	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months. Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	12	781	175	781	247	781
EG001	Saline Solution	Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months. Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).	11	778	205	778	219	778

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0011 affected778 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00014 affected781 at risk EG00112 affected778 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected781 at risk EG0017 affected778 at risk
Angina unstable	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG00110 affected778 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected781 at risk EG0018 affected778 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected781 at risk EG00120 affected778 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00015 affected781 at risk EG00122 affected778 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0011 affected778 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0013 affected778 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected781 at risk EG0016 affected778 at risk
Nodal arrythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Pericarditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0014 affected778 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Ectopic hyperthyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Ophthalmic vein thrombosis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Retinal artery occlusion	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Visual impairment	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Duodenal polyp	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Enteritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Larger intestine perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG0010 affected778 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0013 affected778 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0013 affected778 at risk
Death	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0011 affected778 at risk
Gait disturbance	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Hypothermia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected781 at risk EG0019 affected778 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Sensation of foreign body	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Ulcer haemorrhage	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Vascular stent restenosis	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Anal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0011 affected778 at risk
Appendicitis perforated	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Arthritis infective	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0012 affected778 at risk
Cavernous sinus thrombosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG0012 affected778 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Cystitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Device related infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Diverticultis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0012 affected778 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Gangrene	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Infectious colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0011 affected778 at risk
Localised infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Periotinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00011 affected781 at risk EG0019 affected778 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Post procedural infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0006 affected781 at risk EG0014 affected778 at risk
Sepsis syndrome	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0013 affected778 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Cardiac contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Chemical burn	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Occupational exposure to product	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Post procedural hawmorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Blood pressure increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0010 affected778 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0012 affected778 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0013 affected778 at risk
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0014 affected778 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0012 affected778 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0010 affected778 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Breast cancer stage 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Gastrointestinal lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Liposarcoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0013 affected778 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Myelodyplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG0012 affected778 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0012 affected778 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0011 affected778 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0005 affected781 at risk EG0011 affected778 at risk
Carotid artery disease	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0012 affected778 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG0013 affected778 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Demetia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected781 at risk EG0010 affected778 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0011 affected778 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected781 at risk EG0014 affected778 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Myelopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Nerve compression	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0012 affected778 at risk
Presyncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected781 at risk EG0010 affected778 at risk
Radiculopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Spinal subdural haematoma	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected781 at risk EG0011 affected778 at risk
Status migrainosus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected781 at risk EG0010 affected778 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected781 at risk EG0017 affected778 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00046 affected781 at risk EG00130 affected778 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG000120 affected781 at risk EG001108 affected778 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG00039 affected781 at risk EG00139 affected778 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG00042 affected781 at risk EG00142 affected778 at risk

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

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations