Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibo... | NCT05027074

NCT05027074

ID	Type	Description
MK-2060-007	Other Identifier	MSD
2024-511055-17-00	Registry Identifier	EU CT
U1111-1303-0286	Registry Identifier	UTN
2020-002397-27	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-2060 20 mg	Experimental	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	Drug: MK-2060
MK-2060 6 mg	Experimental	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Drug: MK-2060
Placebo	Placebo Comparator	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MK-2060	Drug	MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion	MK-2060 20 mg MK-2060 6 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to First Arteriovenous Graft (AVG) Thrombosis Event	An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.	From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months

Secondary Outcomes

Measure	Description	Time Frame
Time to Each AVG Thrombosis Event (First and Recurrent)	An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent CAC adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

Eligibility Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nephrology Consultants ( Site 0681)		Huntsville	Alabama	35805	United States
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
FG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1

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_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 14, 2022

Arm/Group Information

ID	Title	Description
BG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
BG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
BG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
BG003	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00062.2± 13.5 BG00158.8± 12.8 BG00260.5± 14.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00097 BG00181 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00077 BG00167 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0011 BG002

Region

Participants were classified based on their geographic region as being either United States (US) or non-US.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
US	BG000118 BG001117 BG002

Previous Thrombosis of Active Arteriovenous Graft (AVG)

Participants were classified based on having previous thrombosis of active AVG, with 'Yes' as having previous thrombosis of active AVG and 'No' as not having previous thrombosis of active AVG.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG00038 BG001

Regular Aspirin Use up to 150 mg Daily at Baseline

Participants were classified based on regular aspirin use up to 150 mg daily at baseline, with 'Yes' as regular use of aspirin up to 150 mg daily at baseline and 'No' as not having regular use of aspirin up to 150 mg daily at baseline.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG00072 BG001

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

Time to First Arteriovenous Graft (AVG) Thrombosis Event

An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

The analysis population consisted of all randomized participants, excluding three participants with arteriovenous fistula (AVF) rather than an AVG at randomization.

Posted

Number

events per 100 person-years

From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months

ID	Title	Description
OG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
OG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
OG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Units	Counts
Participants	OG000171 OG001165 OG002167

Title

Denominators

Categories

Title	Measurements
	OG00023.80 OG00122.98 OG00230.17

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 OG002		Log Rank		0.470	From log-rank test stratified by region (US, Non-US), previous thrombosis of active AVG (yes, no) and regular aspirin use up to 150 mg daily at baseline (yes, no).	Hazard Ratio (HR)	0.87			2-Sided	95	0.60	1.26			HR based on stratified Cox model with Efron's method of tie handling and with a single treatment covariate, controlling for stratification factors of region, previous thrombosis of active AVG and regular aspirin use up to 150 mg daily at baseline.		Superiority

Secondary

Time to Each AVG Thrombosis Event (First and Recurrent)

An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent CAC adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

The analysis population consisted of all randomized participants, excluding three participants with AVF rather than an AVG at randomization.

Posted

Number

events per 100 person-years

Up to approximately 37 months

ID	Title	Description
OG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
OG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
OG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Secondary

Number of Participants Who Experience One or More Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with one or more AEs is presented.

The analysis population consisted of all randomized participants who received at least one dose of study intervention.

Posted

Count of Participants

Participants

Up to approximately 40 months

ID	Title	Description
OG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
OG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
OG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Secondary

Time to First Event of International Society on Thrombosis (ISTH) Major Bleeding Event or a Clinically Relevant Non-Major Bleeding Event

Major bleeding events were defined as a having symptomatic presentation and including ≥1 of the following criteria: 1) Fatal bleeding 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome 3) Bleeding causing decrease in hematocrit level of 20 g/L or more or leading to transfusion of ≥2 units of whole blood or red cells. Clinically relevant non-major bleeding events were defined as signs or symptoms of hemorrhage that do not meet criteria for major bleeding events but meet ≥1 of the following criteria: 1) Requiring medical intervention by healthcare professional 2) Leading to hospitalization or increased level of care 3) Prompting face-to-face evaluation by healthcare professional. A time-to-event methodology was used. The incidence rate is presented.

The analysis population consisted of all randomized participants who received at least one dose of study intervention.

Posted

Number

events per 100 person-years

From date of first dose of study intervention until the first ISTH major bleeding event or a clinically relevant non-major bleeding event. assessed up to approximately 40 months

ID	Title	Description
OG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
OG001	MK-2060 6 mg

Secondary

Number of Participants Who Discontinue Study Intervention Due to an AE

The analysis population consisted of all randomized participants who received at least one dose of study intervention.

Posted

Count of Participants

Participants

Up to approximately 37 months

ID	Title	Description
OG000	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
OG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
OG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

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	MK-2060 20 mg	MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	50	171	110	170	111	170
EG001	MK-2060 6 mg	MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	43	167	95	164	106	164
EG002	Placebo	Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1	41	168	112	168	109	168

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected164 at risk EG0025 events4 affected168 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected164 at risk EG0023 events2 affected168 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG00010 events9 affected170 at risk EG0017 events6 affected164 at risk EG0028 events8 affected168 at risk
Arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0014 events3 affected164 at risk EG0026 events5 affected168 at risk
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0005 events3 affected170 at risk EG0013 events3 affected164 at risk EG0023 events3 affected168 at risk
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG00012 events10 affected170 at risk EG0012 events1 affected164 at risk EG0025 events5 affected168 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0014 events4 affected164 at risk EG0020 events0 affected168 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Coronary artery disease	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Heart failure with preserved ejection fraction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Pericardial effusion	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0021 events1 affected168 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Diplopia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0015 events3 affected164 at risk EG0021 events1 affected168 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Ascites	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Colitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0023 events2 affected168 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0013 events3 affected164 at risk EG0021 events1 affected168 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Stomatitis haemorrhagic	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Ulcerative gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Accidental death	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0023 events3 affected168 at risk
Catheter site haemorrhage	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG00111 events9 affected164 at risk EG0022 events2 affected168 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected170 at risk EG0015 events5 affected164 at risk EG0025 events5 affected168 at risk
Device related thrombosis	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Gait inability	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Generalised oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Impaired healing	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Non-cardiac chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Sudden cardiac death	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Abdominal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Abscess limb	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Appendicitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0007 events6 affected170 at risk EG0011 events1 affected164 at risk EG0022 events2 affected168 at risk
Arthritis infective	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Bacterial infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Bacterial translocation	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Bronchiolitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected170 at risk EG0013 events3 affected164 at risk EG0026 events6 affected168 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Campylobacter infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected170 at risk EG0014 events4 affected164 at risk EG0024 events3 affected168 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Cystitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Device related infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Device related sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Diabetic foot infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Diabetic gangrene	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Diverticulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Encephalitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Endocarditis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Escherichia infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Gangrene	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0023 events3 affected168 at risk
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Graft infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Haematoma infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected170 at risk EG0014 events4 affected164 at risk EG0022 events2 affected168 at risk
Localised infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0023 events2 affected168 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Necrotising soft tissue infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Osteomyelitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0018 events6 affected164 at risk EG0027 events6 affected168 at risk
Parotitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Perirectal abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00013 events10 affected170 at risk EG00110 events9 affected164 at risk EG00214 events13 affected168 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0024 events2 affected168 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Postoperative wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0023 events2 affected168 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pyelitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pyelonephritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0023 events3 affected168 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected170 at risk EG0017 events4 affected164 at risk EG00212 events11 affected168 at risk
Septic encephalopathy	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected170 at risk EG0014 events4 affected164 at risk EG0025 events5 affected168 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG0013 events3 affected164 at risk EG0022 events2 affected168 at risk
Staphylococcal infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events1 affected164 at risk EG0020 events0 affected168 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Urosepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Vascular access site infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Vascular device infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Vascular graft infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Arteriovenous graft site complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected170 at risk EG0010 events0 affected164 at risk EG0024 events4 affected168 at risk
Arteriovenous graft site stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00015 events13 affected170 at risk EG00124 events19 affected164 at risk EG00222 events19 affected168 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Haemodialysis complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0023 events1 affected168 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Vascular access malfunction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0014 events2 affected164 at risk EG0020 events0 affected168 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Vascular access site thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Vascular access site ulcer	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0022 events1 affected168 at risk
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Coma scale abnormal	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Haemoglobin decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Influenza A virus test positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Liver function test increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Occult blood positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Troponin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events1 affected170 at risk EG0010 events0 affected164 at risk EG0023 events3 affected168 at risk
Adult failure to thrive	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0022 events1 affected168 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0024 events2 affected168 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0008 events7 affected170 at risk EG0016 events6 affected164 at risk EG00216 events12 affected168 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00013 events8 affected170 at risk EG00110 events9 affected164 at risk EG00216 events11 affected168 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Bone erosion	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events3 affected164 at risk EG0022 events2 affected168 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Bell's palsy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Cerebral infarction	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Dementia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Hemiparesis	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0022 events1 affected168 at risk
Lacunar stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Presyncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Psychogenic seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Sciatica	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0020 events0 affected168 at risk
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events2 affected164 at risk EG0021 events1 affected168 at risk
Sensory disturbance	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0014 events3 affected164 at risk EG0023 events3 affected168 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Device occlusion	Product Issues	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Delirium	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Depression	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Mental status changes	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events3 affected164 at risk EG0023 events3 affected168 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected170 at risk EG0019 events8 affected164 at risk EG0026 events5 affected168 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG00217 events3 affected168 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0023 events2 affected168 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0021 events1 affected168 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0011 events1 affected164 at risk EG0022 events2 affected168 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0022 events2 affected168 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0022 events2 affected168 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events3 affected164 at risk EG0023 events2 affected168 at risk
Renal transplant	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Therapy cessation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Accelerated hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Aortic stenosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Arterial rupture	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Dialysis hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Extremity necrosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Haematoma	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Hypertensive emergency	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected170 at risk EG0013 events3 affected164 at risk EG0023 events3 affected168 at risk
Hypertensive urgency	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events2 affected164 at risk EG0023 events3 affected168 at risk
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected170 at risk EG0011 events1 affected164 at risk EG0023 events3 affected168 at risk
Hypotensive crisis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Ischaemia	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0020 events0 affected168 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Steal syndrome	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Subclavian vein stenosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Thrombosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected170 at risk EG0011 events1 affected164 at risk EG0020 events0 affected168 at risk
Venous occlusion	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0021 events1 affected168 at risk
Venous stenosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected170 at risk EG0010 events0 affected164 at risk EG0024 events2 affected168 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG00011 events11 affected170 at risk EG0014 events2 affected164 at risk EG0026 events6 affected168 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 events11 affected170 at risk EG00113 events11 affected164 at risk EG00213 events12 affected168 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00017 events11 affected170 at risk EG00126 events20 affected164 at risk EG00211 events9 affected168 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG00012 events9 affected170 at risk EG0013 events3 affected164 at risk EG0026 events6 affected168 at risk
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0009 events9 affected170 at risk EG0017 events6 affected164 at risk EG00211 events10 affected168 at risk
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG00012 events10 affected170 at risk EG0018 events8 affected164 at risk EG00211 events10 affected168 at risk
Puncture site haemorrhage	General disorders	MedDRA 27.1	Systematic Assessment	EG00012 events5 affected170 at risk EG00113 events9 affected164 at risk EG0025 events2 affected168 at risk
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00014 events13 affected170 at risk EG00110 events10 affected164 at risk EG00218 events18 affected168 at risk
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG00012 events10 affected170 at risk EG00112 events7 affected164 at risk EG00211 events8 affected168 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00024 events9 affected170 at risk EG00129 events16 affected164 at risk EG0028 events7 affected168 at risk
Arteriovenous graft site stenosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00031 events22 affected170 at risk EG00151 events23 affected164 at risk EG00239 events23 affected168 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00054 events29 affected170 at risk EG00166 events35 affected164 at risk EG00286 events43 affected168 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG00015 events15 affected170 at risk EG00111 events11 affected164 at risk EG00218 events9 affected168 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG00010 events6 affected170 at risk EG00110 events10 affected164 at risk EG00213 events11 affected168 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected170 at risk EG0017 events6 affected164 at risk EG00214 events10 affected168 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0005 events5 affected170 at risk EG00110 events7 affected164 at risk EG00210 events9 affected168 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG00015 events15 affected170 at risk EG0016 events6 affected164 at risk EG0029 events9 affected168 at risk
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00017 events8 affected170 at risk EG0014 events3 affected164 at risk EG00210 events10 affected168 at risk
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG00011 events9 affected170 at risk EG00113 events10 affected164 at risk EG00218 events14 affected168 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected170 at risk EG0018 events8 affected164 at risk EG00212 events10 affected168 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected170 at risk EG00110 events8 affected164 at risk EG00226 events16 affected168 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG00017 events11 affected170 at risk EG0018 events6 affected164 at risk EG0024 events4 affected168 at risk
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00020 events17 affected170 at risk EG0019 events9 affected164 at risk EG00221 events10 affected168 at risk
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG00012 events12 affected170 at risk EG00110 events7 affected164 at risk EG00232 events15 affected168 at risk

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms