A Study of LY3540378 in Participants With Worsening Chron... | NCT05592275

ID	Type	Description	Link
J3E-MC-EZDB	Other Identifier	Eli Lilly and Company
2023-505902-40-00	Other Identifier	EU Trial Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
25 mg LY3540378	Experimental	Participants received 25 mg LY3540378 administered once weekly as subcutaneous (SC) injection for 26 weeks.	Drug: LY3540378
50 mg LY3540378	Experimental	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.	Drug: LY3540378
100 mg LY3540378	Experimental	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.	Drug: LY3540378
Placebo	Placebo Comparator	Participants received placebo administered once weekly as SC injection for 26 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LY3540378	Drug	Administered SC	100 mg LY3540378 25 mg LY3540378 50 mg LY3540378

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 26	Results are estimated using least squares (LS) mean from the mixed model repeated measures (MMRM) model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + TreatmentTime + BaselineTreatment.	Baseline, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 12	Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + TreatmentTime + BaselineTreatment.	Baseline, Week 12
Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at Week 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Experienced an index event, defined as a recent hospitalization for HF requiring ≥1 bolus doses of intravenous diuretics or an out- of- hospital encounter (for example, Emergency Room, clinic visit, infusion clinic, etc.) for HF requiring ≥1 bolus doses of intravenous diuretics.
Documented LVEF of ≥50% within 12 months prior to screening; as measured by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computerized tomograph (CT).
Evidence of documentation of LVEF of ≥50% may also include participant medical records, discharge notes or a referral letter from the participant's physician or referring physician that details the participant's medical history.
Had evidence of clinical HF syndrome consisting of hospitalization for worsening heart failure (WHF) with intravascular volume overload (the index event), as determined by the investigator, based on appropriate supportive documentation at randomization, and defined by ≥2 of the following:
- dyspnea
- jugular venous distention
- pitting edema in lower extremities (>1+)
- ascites
- pulmonary congestion on chest X-ray
- pulmonary rales AND participant received treatment with IV diuretics.

Treatment for an urgent visit outside of of being hospitalized with WHF and intravascular volume overload (the index visit) requiring treatment with IV diuretics (defined as ≥2 IV doses) such as in the outpatient setting/emergency room/observation unit/infusion clinic with a clinical response within the past 2 weeks prior to randomization. Urgent visit is defined as an unplanned visit for HF defined by ≥2 of the following:
- dyspnea
- jugular venous distention
- pitting edema in lower extremities (>1+)
- ascites
- pulmonary rales on lung examination.
NT-proBNP (>300 [sinus rhythm] or 600 pg/mL [atrial fibrillation or atrial flutter] OR BNP (>100 [sinus rhythm] or 200 pg/mL [atrial fibrillation or atrial flutter]) at screening.
eGFR of >20 mL/min/1.73 m² at V1 (screening; determined by local laboratory), derived from serum creatinine values, age, and sex based on the CKD-EPI equation.

Exclusion Criteria

Prior documentation of low ventricle ejection fraction (LVEF) ≤45% in the past 12 months.
Have had acute coronary syndrome or percutaneous coronary intervention, coronary artery bypass graft, cardiac mechanical support implantation, within 3 months prior to V2. (randomization), - or any other cardiac surgery planned during the study.
Have had left ventricular assist device (LVAD) or cardiac transplantation or have cardiac transplantation planned during the study.
Have hypertrophic cardiomyopathy (obstructive or nonobstructive), restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, known amyloid cardiomyopathy, or inherited cardiomyopathy.
Have a chronic pulmonary/lung disease (COPD), (pulmonary arterial hypertension, etc) as defined by chronic oxygen dependence. Night-time oxygen is not exclusionary.
Uncorrected thyroid disease.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pima Heart		Tucson	Arizona	85719	United States
Valley Clinical Trials, Inc.

PubMed Identifier	Type	Citation	Retractions
40887551	Derived	Borlaug BA, Testani JM, Petrie MC, Wang Z, Cunningham J, Adams KF Jr, Amir O, Belohlavek J, Bocchi E, Freitas A Jr, Hominal M, Kadokami T, Merkely B, Miller CA, Nunez J, Verma S, Yilmaz MB, Oru E, Sam F. Effects of volenrelaxin in worsening heart failure with preserved ejection fraction: a phase 2 randomized trial. Nat Med. 2025 Nov;31(11):3853-3861. doi: 10.1038/s41591-025-03939-6. Epub 2025 Aug 31.

Label	URL
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as subcutaneous (SC) injection for 26 weeks.
FG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.

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 9, 2024	Jan 16, 2026

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
	BG00074.10± 10.08 BG00174.70± 8.14 BG00272.40± 9.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00046 BG00145 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00041 BG00139 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00016 BG00123 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 26

Results are estimated using least squares (LS) mean from the mixed model repeated measures (MMRM) model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

percentage strain

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Units	Counts
Participants	OG00032 OG00137 OG00231 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.924± 1.000 OG001-0.643± 0.926 OG002-1.048± 1.008 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Mixed Models Analysis		0.0058		LS Mean Difference	3.853	Standard Error of the Mean	1.37	2-Sided	95	1.14	6.57					Superiority
OG001 OG003		Mixed Models Analysis		0.3321

Secondary

Change From Baseline in Left Atrial Reservoir Strain (LARS) at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

percentage strain

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

nanogram per liter (ng/L)

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

nanogram per liter (ng/L)

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

millilitres per square metre (mL/m²)

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Left Atrial End-Diastolic Volume Index (LAEDVI) at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mL/m²

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline Left Atrial End-Systolic Volume Index (LAESVI) at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mL/m²

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline Left Atrial End-Systolic Volume Index (LAESVI) at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mL/m²

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

The unit of measure for this outcome is millilitres per minute per 1.73 square metres (mL/min/1.73 m²)

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mL/min/1.73 m²

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mL/min/1.73 m²

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed Serum Creatinine at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed Serum Creatinine at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed Cystatin-C at Week 12

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

milligram per liter (mg/L)

Baseline, Week 12

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

Secondary

Change From Baseline in Log-transformed Cystatin-C at Week 26

Results are estimated using LS mean from the MMRM model: Change from baseline = Baseline + Strata + Gender + Treatment + Time + Treatment*Time + Baseline*Treatment.

All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome.

Posted

Least Squares Mean

Standard Error

mg/L

Baseline, Week 26

ID	Title	Description
OG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
OG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.

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	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.	3	79	19	79	50	79
EG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.	2	83	26	83	57	83
EG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.	3	81	20	81	46	81
EG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.	2	88	15	88	55	88

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 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG0030 events0 affected88 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0022 events2 affected81 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected79 at risk EG00112 events9 affected83 at risk EG00210 events5 affected81 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Chronic left ventricular failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Adrenal haemorrhage	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Erysipelas	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0014 events4 affected83 at risk EG0022 events2 affected81 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Sepsis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Septic shock	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Pneumoconiosis	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Presyncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Syncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Breast enlargement	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Endometrial atrophy	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected45 at risk EG0020 events0 affected44 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected45 at risk EG0020 events0 affected44 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0013 events2 affected83 at risk EG0021 events1 affected81 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Nephrectomy	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0008 events8 affected79 at risk EG0016 events6 affected83 at risk EG0025 events5 affected81 at risk EG0033 events3 affected88 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Bicytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0012 events2 affected83 at risk EG0021 events1 affected81 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Splenic cyst	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0016 events6 affected83 at risk EG0026 events5 affected81 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG00014 events8 affected79 at risk EG00114 events11 affected83 at risk EG0029 events7 affected81 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Heart alternation	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Heart failure with preserved ejection fraction	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cataract	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Diplopia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Eye haematoma	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Photophobia	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Visual impairment	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0013 events3 affected83 at risk EG0020 events0 affected81 at risk EG003
Defaecation urgency	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0015 events4 affected83 at risk EG0021 events1 affected81 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0013 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Oral mucosal eruption	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Administration site erythema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Asthenia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0013 events3 affected83 at risk EG0024 events4 affected81 at risk EG003
Chest discomfort	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Discomfort	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Drug intolerance	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0013 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Fatigue	General disorders	MedDRA 27.1	Systematic Assessment	EG0004 events3 affected79 at risk EG0010 events0 affected83 at risk EG0024 events3 affected81 at risk EG003
Generalised oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Injection site bruising	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0022 events1 affected81 at risk EG003
Injection site pruritus	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Injection site reaction	General disorders	MedDRA 27.1	Systematic Assessment	EG0002 events1 affected79 at risk EG00119 events2 affected83 at risk EG0025 events3 affected81 at risk EG003
Localised oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Malaise	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Oedema	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.1	Systematic Assessment	EG0006 events5 affected79 at risk EG0015 events5 affected83 at risk EG0021 events1 affected81 at risk EG003
Pain	General disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Peripheral swelling	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Pyrexia	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0022 events2 affected81 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Asymptomatic bacteriuria	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Bacteriuria	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events5 affected79 at risk EG0012 events2 affected83 at risk EG0023 events3 affected81 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events2 affected83 at risk EG0023 events3 affected81 at risk EG003
Dengue fever	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Ear infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0022 events1 affected81 at risk EG003
Erysipelas	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Eye infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Influenza	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected79 at risk EG0015 events4 affected83 at risk EG0021 events1 affected81 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Laryngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Localised infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0006 events5 affected79 at risk EG0013 events3 affected83 at risk EG0021 events1 affected81 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0014 events2 affected83 at risk EG0022 events2 affected81 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Rhinitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Skin infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Tooth infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0013 events3 affected83 at risk EG0021 events1 affected81 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0007 events7 affected79 at risk EG0014 events4 affected83 at risk EG0024 events3 affected81 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Wound infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Cataract operation complication	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0014 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0012 events2 affected83 at risk EG0021 events1 affected81 at risk EG003
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Underdose	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0022 events1 affected81 at risk EG003
Blood calcium increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood glucose increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood potassium decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Blood uric acid increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Body temperature increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
C-reactive protein increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardiac murmur	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Colonoscopy	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Gamma-glutamyltransferase abnormal	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Haematocrit decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0013 events3 affected83 at risk EG0020 events0 affected81 at risk EG003
Inflammatory marker increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Oxygen saturation increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Platelet count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Red blood cell count decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Sars-cov-2 test positive	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Transaminases increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Urine output decreased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Volume blood increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Weight increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Calcium deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Folate deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Food aversion	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0013 events1 affected83 at risk EG0023 events2 affected81 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0012 events2 affected83 at risk EG0022 events2 affected81 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0014 events4 affected83 at risk EG0022 events2 affected81 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected79 at risk EG0013 events3 affected83 at risk EG0021 events1 affected81 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected79 at risk EG0012 events2 affected83 at risk EG0022 events1 affected81 at risk EG003
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0010 events0 affected38 at risk EG0020 events0 affected37 at risk EG003
Tumour of ampulla of vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0012 events2 affected83 at risk EG0025 events4 affected81 at risk EG003
Essential tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Headache	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Presyncope	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Sciatica	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Tremor	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0022 events2 affected81 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Discouragement	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Albuminuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Microalbuminuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0021 events1 affected81 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0012 events2 affected83 at risk EG0023 events2 affected81 at risk EG003
Urethral haemorrhage	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected38 at risk EG0020 events0 affected37 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Genital erythema	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Genital haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected38 at risk EG0020 events0 affected37 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected45 at risk EG0021 events1 affected44 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected45 at risk EG0020 events0 affected44 at risk EG003
Varicocele	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected38 at risk EG0020 events0 affected37 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected45 at risk EG0021 events1 affected44 at risk EG003
Catarrh	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0013 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0006 events6 affected79 at risk EG0013 events3 affected83 at risk EG0023 events3 affected81 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0012 events1 affected83 at risk EG0024 events2 affected81 at risk EG003
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0002 events2 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected79 at risk EG0012 events2 affected83 at risk EG0020 events0 affected81 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Skin depigmentation	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Cardioversion	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Cataract operation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Coronary revascularisation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Drainage	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Intraocular lens implant	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Joint injection	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Vaginal pessary removal	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected46 at risk EG0010 events0 affected45 at risk EG0021 events1 affected44 at risk EG003
Vocal cord polypectomy	Surgical and medical procedures	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Blood pressure inadequately controlled	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events3 affected79 at risk EG0017 events5 affected83 at risk EG0028 events5 affected81 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0003 events2 affected79 at risk EG0018 events1 affected83 at risk EG0025 events4 affected81 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected79 at risk EG0010 events0 affected83 at risk EG0020 events0 affected81 at risk EG003
Varicose ulceration	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0010 events0 affected83 at risk EG0021 events1 affected81 at risk EG003
Varicose vein	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected79 at risk EG0011 events1 affected83 at risk EG0020 events0 affected81 at risk EG003

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	25 mg LY3540378	Participants received 25 mg LY3540378 administered once weekly as SC injection for 26 weeks.
BG001	50 mg LY3540378	Participants received 50 mg LY3540378 administered once weekly as SC injection for 26 weeks.
BG002	100 mg LY3540378	Participants received 100 mg LY3540378 administered once weekly as SC injection for 26 weeks.
BG003	Placebo	Participants received placebo administered once weekly as SC injection for 26 weeks.
BG004	Total	Total of all reporting groups