Safety and Tolerability of Abelacimab (MAA868) vs. Rivaro... | NCT04755283

ID	Type	Description	Link
2020-004507-13	EudraCT Number
CMAA868A2204	Other Identifier	Novartis

Status Module

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Oversight 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
Abelacimab 90 mg (MAA868)	Experimental	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly	Biological: Abelacimab
Abelacimab 150 mg (MAA868)	Experimental	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Extension Treatment Group: Abelacimab high dose subcutaneous (s.c.) monthly	Biological: Abelacimab
Rivaroxaban	Active Comparator	Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Patients with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily.	Drug: Rivaroxaban

Name	Type	Description	Arm Group Labels	Other Names
Abelacimab	Biological	Abelacimab provided as liquid in vial (150 mg/mL)	Abelacimab 150 mg (MAA868) Abelacimab 90 mg (MAA868)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events	The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.	Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

Secondary Outcomes

Measure	Description	Time Frame
Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events	The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Anthos Investigative Site		Huntsville	Alabama	35801	United States
Anthos Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39842011	Result	Ruff CT, Patel SM, Giugliano RP, Morrow DA, Hug B, Kuder JF, Goodrich EL, Chen SA, Goodman SG, Joung B, Kiss RG, Spinar J, Wojakowski W, Weitz JI, Murphy SA, Wiviott SD, Parkar S, Bloomfield D, Sabatine MS; AZALEA-TIMI 71 Investigators. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025 Jan 23;392(4):361-371. doi: 10.1056/NEJMoa2406674.
42213637

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
FG001	Abelacimab 150 mg (MAA868)

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	Apr 18, 2023	Mar 19, 2025

Arm/Group Information

ID	Title	Description
BG000	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
BG001	Abelacimab 150 mg (MAA868)	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
BG002	Rivaroxaban	Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
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, Customized

Count of Participants

Participants

Title	Denominators	Categories
≥ 80 years	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002430 ParticipantsBG003

Sex/Gender, Customized

Count of Participants

Participants

Title	Denominators	Categories
Female sex	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Race/Ethnicity, Customized

Race was reported by the participant.

Count of Participants

Participants

Title	Denominators	Categories
White	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Median Age

Median

Inter-Quartile Range

years

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Median body-mass index (IQR)

The body-mass index is the weight in kilograms divided by the square of the height in meters. Data were missing for one participant in the 150-mg abelacimab group.

Median

Inter-Quartile Range

kg/m²

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Creatinine clearance ≤50 ml/min

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000425 ParticipantsBG001430 ParticipantsBG002

Pattern of atrial fibrillation

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
First detected or paroxysmal	ParticipantsBG000426 ParticipantsBG001424 ParticipantsBG002

Median CHA₂DS₂-VASc score

CHA₂DS₂-VASc scores range from 0 to 9, with higher scores indicating a greater risk of stroke. Congestive heart failure, hypertension, age of 65 to 74 years, diabetes, vascular disease, and female sex are each assigned 1 point; age of 75 years or older, previous stroke, transient ischemic attack, and previous thromboembolism are each assigned 2 points.

Median

Inter-Quartile Range

score

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

CHA₂DS₂-VASc score

CHA2DS2-VASc scores range from 0 to 9, with higher scores indicating a greater risk of stroke. Congestive heart failure, hypertension, age of 65 to 74 years, diabetes, vascular disease, and female sex are each assigned 1 point; age of 75 years or older, previous stroke, transient ischemic attack, and previous thromboembolism are each assigned 2 points.

Count of Participants

Participants

Title	Denominators	Categories
≤4	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Median HAS-BLED score

Modified HAS-BLED scores range from 0 to 8, with higher scores indicating a greater risk of bleeding. Hypertension, abnormal renal function, abnormal liver function, previous stroke, predisposition to bleeding, labile international normalized ratio (not assessed in this trial, so no points assigned for this variable), age greater than 65 years, concomitant use of aspirin or nonsteroidal antiinflammatory drugs, and excessive alcohol use are each assigned 1 point.

Median

Inter-Quartile Range

score

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430

HAS-BLED score ≥3

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430

Hypertension

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Diabetes

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Heart failure

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Coronary artery disease

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Previous ischemic stroke

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000427 ParticipantsBG001430 ParticipantsBG002

Previous transient ischemic attack

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000426 ParticipantsBG001429 ParticipantsBG002

History of bleeding

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
Any bleeding	ParticipantsBG000424 ParticipantsBG001425 ParticipantsBG002

Anticoagulation ≥60 days

The number analyzed reflects the available data for this characteristic rather than the total number of randomized participants, resulting in varying denominators.

Count of Participants

Participants

Title	Denominators	Categories
Anticoagulation ≥60 days	ParticipantsBG000426 ParticipantsBG001430 ParticipantsBG002

Planned concomitant antiplatelet medication

The number of participants with planned concomitant antiplatelet medication are presented.

Count of Participants

Participants

Title	Denominators	Categories
Aspirin	ParticipantsBG000107 ParticipantsBG001105 ParticipantsBG002

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

Incidence Rate of the First Occurrence of Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major Bleeding or Clinically Relevant Non-Major (CRNM) Bleeding Events

The number of participants experiencing the first occurrence of the composite of ISTH-defined major bleeding or CRNM bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

The analysis population is the number of randomized participants who received at least one dose of study treatment. The difference between the overall number of participants analyzed and the overall number of participants assigned to the arm represents those who never received a dose of study treatment.

Posted

Number

participants with event/100 person-years

Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

ID	Title	Description
OG000	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG001	Abelacimab 150 mg (MAA868)	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG002	Rivaroxaban	Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets

Units	Counts
Participants	OG000425 OG001427 OG002428

Title

Denominators

Categories

Title	Measurements
	OG0002.64 OG0013.22 OG0028.39

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		Stratified Log Rank Test	Stratified for stratification factors	<0.001		Hazard Ratio (HR)	0.314			2-Sided	95	0.192	0.513			Cox Proportional Hazards Model Adjusted for Stratification Factors		Superiority
OG001 OG002

Secondary

Incidence Rate of the First Occurrence of ISTH-defined Major Bleeding Events

The number of participants experiencing the first occurrence of ISTH-defined major bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Posted

Number

participants with event/100 person-years

Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

ID	Title	Description
OG000	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG001	Abelacimab 150 mg (MAA868)	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG002	Rivaroxaban

Secondary

Incidence Rate of the First Occurrence of ISTH-defined Major or CRNM or Minor Bleeding Events

The number of participants experiencing the first occurrence of the composite of ISTH-defined major or CRNM or minor bleeding events divided by the number of 100 person-years through the first event or end of treatment across all participants, is presented. For participants not experiencing events, person-years is calculated through the end of treatment during the randomized phase.

Posted

Number

participants with event/100 person-years

Assessed at every visit from randomization through the end of the randomized phase of the study, up to 33 months.

ID	Title	Description
OG000	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG001	Abelacimab 150 mg (MAA868)	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)
OG002

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	Abelacimab 90 mg (MAA868)	Treatment group 1: Abelacimab low dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	31	427	158	425	215	425
EG001	Abelacimab 150 mg (MAA868)	Treatment group 2: Abelacimab high dose subcutaneous (s.c.) monthly Abelacimab: Abelacimab provided as liquid in vial (150 mg/mL)	36	430	157	427	257	427
EG002	Rivaroxaban	Treatment group 3: Rivaroxaban 20 mg by mouth; orally (p.o.) once per day with the evening meal Participants with a Creatinine Clearance (CrCl) ≤50 ml/min by the Cockcroft-Gault equation will have a dose adaptation to rivaroxaban 15 mg p.o. daily. Rivaroxaban: Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets	34	430	167	428	227	428

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected425 at risk EG00111 events10 affected427 at risk EG00215 events13 affected428 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected425 at risk EG0011 events1 affected427 at risk EG0023 events3 affected428 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected425 at risk EG0013 events3 affected427 at risk EG0025 events5 affected428 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected425 at risk EG0017 events7 affected427 at risk EG0022 events1 affected428 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected425 at risk EG0012 events2 affected427 at risk EG0023 events3 affected428 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events4 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected427 at risk EG0021 events1 affected428 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Arthritis bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Endocarditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Erysipelas	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Bronchitis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Bursitis infective	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cholecystitis infective	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Citrobacter sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Colonic abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events1 affected428 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events1 affected428 at risk
Epididymitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Febrile infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Gangrene	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Implant site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Keratouveitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Kidney infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Otitis externa	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Peritonitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pneumonia viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Vulvitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0013 events3 affected427 at risk EG0021 events1 affected428 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0013 events3 affected427 at risk EG0021 events1 affected428 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Hormone receptor positive breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Meningionma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG00218 events1 affected428 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Non-small cell lung cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0013 events3 affected427 at risk EG00213 events11 affected428 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Bone marrow disorder	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Food allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Mental status changes	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Major depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Suicidal behaviour	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected425 at risk EG0015 events4 affected427 at risk EG0024 events3 affected428 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected425 at risk EG0013 events3 affected427 at risk EG0023 events3 affected428 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0014 events4 affected427 at risk EG0020 events0 affected428 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0023 events3 affected428 at risk
Seizure	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Embolic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Axonal and demyelinating polyneuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Dementia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Essential tremor	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Focal dyscognitive seizures	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Intracranial mass	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Loss of consciousness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Middle cerebral artery stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Partial seizures	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Sciatica	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Retinal detachment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Vitreoretinal traction syndrome	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG00038 events26 affected425 at risk EG00123 events20 affected427 at risk EG00232 events18 affected428 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG00027 events18 affected425 at risk EG00118 events14 affected427 at risk EG00212 events10 affected428 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected425 at risk EG0013 events3 affected427 at risk EG0029 events7 affected428 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0016 events6 affected427 at risk EG00211 events6 affected428 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected425 at risk EG0012 events2 affected427 at risk EG0024 events4 affected428 at risk
Angina unstable	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0013 events3 affected427 at risk EG0024 events4 affected428 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected425 at risk EG0013 events3 affected427 at risk EG0023 events3 affected428 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected425 at risk EG0011 events1 affected427 at risk EG0024 events4 affected428 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0012 events2 affected427 at risk EG0022 events2 affected428 at risk
Bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected427 at risk EG0023 events3 affected428 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected427 at risk EG0025 events3 affected428 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0012 events2 affected427 at risk EG0021 events1 affected428 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0024 events3 affected428 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events1 affected427 at risk EG0020 events0 affected428 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0013 events2 affected427 at risk EG0020 events0 affected428 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Arrhythmia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pericarditis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Aortic stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0011 events1 affected427 at risk EG0022 events2 affected428 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0012 events1 affected427 at risk EG0025 events2 affected428 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0012 events2 affected427 at risk EG0021 events1 affected428 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0013 events3 affected427 at risk EG0020 events0 affected428 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Arteriosclerosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Haematoma	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Aortic aneurysm	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Arterial stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Circulatory collapse	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Hypertensive crisis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Hypertensive urgency	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Lymphoedema	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Peripheral vascular haematoma	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected425 at risk EG0013 events2 affected427 at risk EG0029 events6 affected428 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00010 events7 affected425 at risk EG0013 events3 affected427 at risk EG00213 events5 affected428 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected425 at risk EG0011 events1 affected427 at risk EG0023 events2 affected428 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Epiglottis dysfunction	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events1 affected427 at risk EG0020 events0 affected428 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0013 events3 affected427 at risk EG00214 events12 affected428 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0014 events4 affected427 at risk EG0022 events2 affected428 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0014 events3 affected427 at risk EG0023 events2 affected428 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0024 events2 affected428 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0023 events2 affected428 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Bowel movement irregularity	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Enterocele	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Melaena	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events1 affected428 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0021 events1 affected428 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cholestatis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0023 events1 affected428 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Angiodermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Scar discomfort	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected425 at risk EG0013 events3 affected427 at risk EG0022 events2 affected428 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events1 affected428 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected425 at risk EG0012 events1 affected427 at risk EG0026 events6 affected428 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0012 events2 affected427 at risk EG0022 events1 affected428 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0013 events3 affected427 at risk EG0020 events0 affected428 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Renal colic	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Renal mass	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0024 events4 affected428 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected425 at risk EG0014 events4 affected427 at risk EG0026 events6 affected428 at risk
Sudden cardiac death	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0014 events4 affected427 at risk EG0022 events2 affected428 at risk
Sudden death	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0023 events3 affected428 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0012 events2 affected427 at risk EG0020 events0 affected428 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Granuloma	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Necrosis	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Stent-graft endoleak	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Blood pressure increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Blood sodium decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Troponin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0012 events2 affected427 at risk EG0024 events4 affected428 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected425 at risk EG0011 events1 affected427 at risk EG0022 events2 affected428 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0023 events2 affected428 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0022 events2 affected428 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0022 events2 affected428 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0021 events1 affected428 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected425 at risk EG0010 events0 affected427 at risk EG0020 events0 affected428 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Device malfunction	Product Issues	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected425 at risk EG0011 events1 affected427 at risk EG0020 events0 affected428 at risk
Lead dislodgement	Product Issues	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected425 at risk EG0010 events0 affected427 at risk EG0021 events1 affected428 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00042 events41 affected425 at risk EG00149 events48 affected427 at risk EG00246 events45 affected428 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG00039 events28 affected425 at risk EG00134 events27 affected427 at risk EG00231 events24 affected428 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00026 events23 affected425 at risk EG00131 events26 affected427 at risk EG00229 events27 affected428 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00025 events24 affected425 at risk EG00127 events26 affected427 at risk EG00222 events20 affected428 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00021 events20 affected425 at risk EG00129 events26 affected427 at risk EG00224 events22 affected428 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00038 events27 affected425 at risk EG00127 events24 affected427 at risk EG00212 events12 affected428 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00023 events18 affected425 at risk EG00118 events17 affected427 at risk EG00229 events24 affected428 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00015 events10 affected425 at risk EG00136 events27 affected427 at risk EG00219 events15 affected428 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00015 events13 affected425 at risk EG00133 events27 affected427 at risk EG00214 events11 affected428 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00014 events11 affected425 at risk EG00112 events9 affected427 at risk EG00241 events27 affected428 at risk

Certain Agreements

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds