A Research Study to See How Semaglutide Works Compared to... | NCT03819153

ID	Type	Description
U1111-1217-6259	Other Identifier	World Health Organization (WHO)
2018-002878-50	Registry Identifier	European Medicines Agency (EudraCT)
JapicCTI-194843	Registry Identifier	JAPIC (Japan)

Label	Type	Description	Intervention Names
Semaglutide	Experimental	Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.	Drug: Semaglutide
Placebo	Placebo Comparator	Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.	Drug: Placebo (semaglutide)

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Measure	Description	Time Frame
Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death	Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration [CKD-EPI]), onset of persistent eGFR (CKD-EPI) <15 milliliter per minute per 1.73 meter square (mL/min/1.73m^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.	From Week 0 up to Week 234

Measure	Description	Time Frame
Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)	Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Name	Affiliation	Role
Clinical Transparency (dept. 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Terence Hart		Tuscumbia	Alabama	35674	United States
California Inst Of Renal Res

PubMed Identifier	Type	Citation	Retractions
36651820	Background	Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009.
42233552

ID	Title	Description
FG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 25, 2021	Jan 8, 2025

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

Number of Participants From Time of Randomization to First Occurrence of Onset of Persistent ≥50% Reduction in eGFR(CKD-EPI); Onset of Persistent eGFR(CKD-EPI) <15mL/Min/1.73m^2; Initiation of Chronic Renal Replacement Therapy; Renal Death; CV Death

Number of participants with first composite renal event i.e., from time of randomization to first occurrence of an onset of persistent greater than or equal to (≥) 50 percent (%) reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease - epidemiology collaboration [CKD-EPI]), onset of persistent eGFR (CKD-EPI) <15 milliliter per minute per 1.73 meter square (mL/min/1.73m^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation), renal death, and cardiovascular (CV) death combined data were reported in this outcome measure.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Units	Counts
Participants	OG0001767 OG0011766

Title

Denominators

Categories

Title	Measurements
	OG000331 OG001410

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.	Regression, Cox		0.0001		Hazard Ratio (HR)	0.76			2-Sided	95	0.66	0.88					Superiority

Secondary

Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)

Annual rate of change in Total eGFR slope CKD-EPI were reported from baseline at Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Mean

Standard Error

(mL/min/1.73 m^2)/year

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Occurrence of Onset of Persistent ≥50% Reduction in eGFR (CKD-EPI)

Number of participants from time of randomization to time to occurrence of onset of persistent ≥50% reduction in eGFR (CKD-EPI) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Occurrence of Onset of Persistent eGFR (CKD-EPI) <15mL/Min/1.73m^2

Number of participants from time of randomization to time to occurrence of onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73m^2 were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy

Number of participants from time of randomization to time to occurrence of initiation of chronic renal replacement therapy (dialysis or kidney transplantation) were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Occurrence of Renal Death

Number of participants from time of randomization to time to occurrence of renal death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Occurrence of CV Death

Number of participants from time of randomization to time to occurrence of CV death were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope)

Annual rate of change in eGFR in terms of chronic kidney disease CKD-EPI were reported from Week 12 to Week 234 in-trial period. eGFR was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.

Posted

Mean

Standard Error

mL/min/1.73 m^2

Week 12, Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in eGFR (CKD-EPI) at Week 12

Change from baseline in eGFR at Week 12 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline (Week 0), Week 12

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104

Changes from baseline in eGFR (cystatin C) at Week 104 in-trial period were reported. Cystatin C was calculated using the CKD-EPI formula. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Baseline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline

Change from baseline in UACR (ratio to baseline) at Week 104 in-trial period were reported. For UACR, the baseline assessment is defined as the mean of the two assessments from the randomization visit. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

Baseline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Time to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Acute Myocardial Infarction (Non Fatal); Non-fatal Stroke; and CV Death

Number of participants who reported first occurence of non-fatal acute myocardial infarction, non-fatal stroke, and CV death combined data were presented from Week 0 up to Week 234 during on-treatment period. MACE consisted of non-fatal acute myocardial infarction, cardiovascular death and non-fatal stroke. First on-treatment period is defined as period from date of first dose until first time where no dose had been administered within 5 weeks (35 days) or end of the in-trial period, whichever came first.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Time to Occurrence of All-cause Death

Number of participants who reported occurence of deaths from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Myocardial Infarction

Number of participants who reported occurrence of non-fatal acute myocardial infarction from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Time to Occurrence of Each of the Individual Components of the Confirmatory Secondary MACE Endpoint: Non-fatal Stroke

Number of participants who reported occurrence of non-fatal stroke from Week 0 up to Week 234 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants From Time of Randomization to Time to First Occurrence of Major Adverse Limb Events (MALE): Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization

Number of participants with combined data of first occurence of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during on-treatment period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Participants With Acute Limb Ischaemia Hospitalization and Chronic Limb Ischaemia Hospitalization

Number of participants of acute limb ischaemia hospitalization and chronic limb ischaemia hospitalization from Week 0 up to Week 234 during in-trial period were presented. MALE consisted of acute and chronic limb ischaemia hospitalisation. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Count of Participants

Participants

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in Body Weight at Week 104

Change in body weight from Week 0 up to Week 104 during in-trial period, measured in kilograms, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

Kilograms

Baeline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 104

Change in HbA1c from Week 0 to Week 104 during in-trial period, measured in percentage point of HbA1c, were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in Systolic Blood Pressure at Week 104

Change in systolic blood pressure from Week 0 to Week 104 during in-trial period were presented. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

Millimeters of mercury

Baseline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Change From Baseline in Diastolic Blood Pressure at Week 104

Change in diastolic blood pressure from Week 0 to Week 104 during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

Posted

Mean

Standard Deviation

millimeters of mercury

Baseline (Week 0), Week 104

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Secondary

Number of Severe Hypoglycaemic Episodes

The number of severe hypoglycaemic episodes (such as the seriousness of hypoglycaemia, contributing factors, seizures, and unconsciousness; classified by American Diabetes Association) observed during the in-trial period were reported in this endpoint. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when participant withdrew consent, date of last contact with participant (for participant lost to follow-up), and date of death.

FAS included all unique randomized participants who were grouped according to the treatment assigned at randomization.

Posted

Number

Episodes

From Week 0 up to Week 234

ID	Title	Description
OG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
OG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abdominal hernia repair	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0005 events4 affected1,767 at risk EG0016 events6 affected1,766 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Abscess limb	Infections and infestations	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0013 events2 affected1,766 at risk
Accelerated hypertension	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events4 affected1,766 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG000165 events124 affected1,767 at risk EG001143 events123 affected1,766 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0016 events6 affected1,766 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00052 events49 affected1,767 at risk EG00181 events67 affected1,766 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG00113 events12 affected1,766 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG00031 events30 affected1,767 at risk EG00137 events32 affected1,766 at risk
Acute sinusitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0012 events2 affected1,766 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0017 events7 affected1,766 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Albuminuria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Amyloidosis	Immune system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG00025 events18 affected1,767 at risk EG00128 events24 affected1,766 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Anal abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Anal fissure haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Anal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Angina pectoris	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00016 events13 affected1,767 at risk EG00116 events16 affected1,766 at risk
Angina unstable	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00012 events12 affected1,767 at risk EG00124 events22 affected1,766 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Angiolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Angiopathy	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0015 events5 affected1,766 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Antisynthetase syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Anuria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Aortic aneurysm	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0014 events4 affected1,766 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0010 events0 affected1,766 at risk
Aortic dilatation	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Aortic dissection	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Aortic stenosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0007 events7 affected1,767 at risk EG0012 events2 affected1,766 at risk
Aortic thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Aortoenteric fistula	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Appendicitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG0015 events5 affected1,766 at risk
Appendicitis perforated	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Arrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0013 events3 affected1,766 at risk
Arterial disorder	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Arteriosclerosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Arthritis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0007 events4 affected1,767 at risk EG0015 events5 affected1,766 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ascites	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Asthenia	General disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0017 events7 affected1,766 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ataxia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00035 events31 affected1,767 at risk EG00131 events22 affected1,766 at risk
Atrial flutter	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00014 events11 affected1,767 at risk EG00110 events7 affected1,766 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0006 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events4 affected1,766 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0012 events2 affected1,766 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Azotaemia	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0013 events3 affected1,766 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
B-cell small lymphocytic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG0013 events3 affected1,766 at risk
Bacteraemia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0015 events5 affected1,766 at risk
Bacterial infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bacterial prostatitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bacterial sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Behcet's syndrome	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bell's palsy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Benign duodenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Benign neoplasm of eyelid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events4 affected1,766 at risk
Biliary tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bladder squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Blepharitis	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Blindness unilateral	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Blood bilirubin increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Blood creatinine increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Blood folate decreased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Blood glucose abnormal	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Blood glucose fluctuation	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Blood potassium increased	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Bone abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bradycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0007 events6 affected1,767 at risk EG0016 events6 affected1,766 at risk
Brain compression	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Brain injury	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Brain natriuretic peptide increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Brain oedema	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Brain stem infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Brain stem stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Bronchitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0017 events7 affected1,766 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0014 events4 affected1,766 at risk
Bursitis infective	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
COVID-19	Infections and infestations	MedDRA 26	Systematic Assessment	EG00059 events58 affected1,767 at risk EG00174 events74 affected1,766 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG00068 events68 affected1,767 at risk EG00183 events83 affected1,766 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Candida infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Candida sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Carbuncle	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00018 events16 affected1,767 at risk EG00114 events14 affected1,766 at risk
Cardiac asthma	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardiac death	General disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardiac failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00063 events48 affected1,767 at risk EG00189 events66 affected1,766 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00030 events27 affected1,767 at risk EG00132 events26 affected1,766 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00019 events18 affected1,767 at risk EG00119 events18 affected1,766 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00040 events33 affected1,767 at risk EG00156 events49 affected1,766 at risk
Cardiac hypertrophy	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0015 events5 affected1,766 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0016 events6 affected1,766 at risk
Cardiomegaly	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0013 events3 affected1,766 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0008 events7 affected1,767 at risk EG0013 events3 affected1,766 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cataract	Eye disorders	MedDRA 26	Systematic Assessment	EG00027 events22 affected1,767 at risk EG00116 events13 affected1,766 at risk
Cataract operation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cellulitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG00017 events12 affected1,767 at risk EG00131 events26 affected1,766 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Central cord syndrome	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cerebral cyst	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events4 affected1,766 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00012 events11 affected1,767 at risk EG0015 events5 affected1,766 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00015 events15 affected1,767 at risk EG00113 events13 affected1,766 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Chagas' cardiomyopathy	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Chest discomfort	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Chest pain	General disorders	MedDRA 26	Systematic Assessment	EG0009 events9 affected1,767 at risk EG0015 events5 affected1,766 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cholangitis infective	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG00012 events12 affected1,767 at risk EG00116 events15 affected1,766 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG00013 events13 affected1,767 at risk EG00112 events12 affected1,766 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cholestatic liver injury	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Chorioretinitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Chromophobe renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG00048 events42 affected1,767 at risk EG00137 events37 affected1,766 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Chronic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0007 events6 affected1,767 at risk EG00110 events9 affected1,766 at risk
Chronic respiratory disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Circulatory collapse	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Claudication of jaw muscles	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events2 affected1,766 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Clostridium colitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Colitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0014 events4 affected1,766 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0013 events3 affected1,766 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Colon cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0011 events1 affected1,766 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Colpocele	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Coma	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Complicated appendicitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Complication associated with device	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Confusional state	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0011 events1 affected1,766 at risk
Constipation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0016 events5 affected1,766 at risk
Contrast media allergy	Immune system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Contrast media toxicity	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Cor pulmonale	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00037 events31 affected1,767 at risk EG00129 events28 affected1,766 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00011 events8 affected1,767 at risk EG00111 events10 affected1,766 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Coronary vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Coronavirus infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Coronavirus pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cranial nerve paralysis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Cystitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Death	General disorders	MedDRA 26	Systematic Assessment	EG00021 events21 affected1,767 at risk EG00130 events30 affected1,766 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG0017 events5 affected1,766 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG00013 events10 affected1,767 at risk EG00110 events10 affected1,766 at risk
Delirium	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0013 events3 affected1,766 at risk
Dementia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0010 events0 affected1,766 at risk
Dengue fever	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Depression	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0012 events1 affected1,766 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Device malfunction	Product Issues	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Device occlusion	Product Issues	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Device related infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0015 events4 affected1,766 at risk
Device related sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Device related thrombosis	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0015 events5 affected1,766 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0017 events7 affected1,766 at risk
Diabetic autonomic neuropathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Diabetic complication renal	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Diabetic end stage renal disease	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG00014 events11 affected1,767 at risk EG00112 events12 affected1,766 at risk
Diabetic foot infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0008 events6 affected1,767 at risk EG0018 events7 affected1,766 at risk
Diabetic gangrene	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG00012 events10 affected1,767 at risk EG0019 events7 affected1,766 at risk
Diabetic macroangiopathy	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0016 events6 affected1,766 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG00012 events9 affected1,767 at risk EG0016 events5 affected1,766 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Diabetic retinopathy	Eye disorders	MedDRA 26	Systematic Assessment	EG00015 events12 affected1,767 at risk EG0019 events9 affected1,766 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00011 events10 affected1,767 at risk EG0014 events4 affected1,766 at risk
Dilatation intrahepatic duct congenital	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Diverticulitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Dizziness	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Dizziness postural	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Dry gangrene	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG00012 events9 affected1,767 at risk EG00112 events11 affected1,766 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Embolic stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0014 events4 affected1,766 at risk
Embolism arterial	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Emphysematous cystitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Encephalomalacia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0008 events7 affected1,767 at risk EG0013 events3 affected1,766 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG00033 events31 affected1,767 at risk EG00137 events36 affected1,766 at risk
Endocarditis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Endophthalmitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Enterocolitis viral	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Epilepsy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Epiretinal membrane	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Erysipelas	Infections and infestations	MedDRA 26	Systematic Assessment	EG0008 events7 affected1,767 at risk EG0013 events3 affected1,766 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Escherichia infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Escherichia sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Exfoliation glaucoma	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Extremity necrosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Eye infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Eyelid ptosis	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Facial paralysis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG00018 events17 affected1,767 at risk EG00121 events20 affected1,766 at risk
Fatigue	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Febrile infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events4 affected1,766 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Flatback syndrome	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Fournier's gangrene	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Fungal peritonitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gait disturbance	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Gallbladder empyema	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gallbladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gangrene	Infections and infestations	MedDRA 26	Systematic Assessment	EG00014 events10 affected1,767 at risk EG00112 events11 affected1,766 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastric cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastroenteritis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG0016 events6 affected1,766 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0009 events9 affected1,767 at risk EG00110 events10 affected1,766 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
General physical health deterioration	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
General symptom	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Generalised oedema	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0014 events4 affected1,766 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Glaucoma	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Glomerular filtration rate abnormal	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Glomerulonephritis proliferative	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Goitre	Endocrine disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0015 events4 affected1,766 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haematoma	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Haematoma infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haematuria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0014 events4 affected1,766 at risk
Haemobilia	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haemodialysis	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemodialysis complication	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemodynamic instability	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemophilus infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events2 affected1,766 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0015 events5 affected1,766 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hallucination	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Headache	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0013 events3 affected1,766 at risk
Hemiparesis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0014 events3 affected1,766 at risk
Hepatic enzyme increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatitis B	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hernia	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Herpes virus infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Herpes zoster	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Herpes zoster infection neurological	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0013 events3 affected1,766 at risk
Hip surgery	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hydrocephalus	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG00011 events8 affected1,767 at risk EG00115 events11 affected1,766 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG00018 events15 affected1,767 at risk EG00124 events23 affected1,766 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hyperplasia	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hyperpyrexia	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypersensitivity	Immune system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypertension	Vascular disorders	MedDRA 26	Systematic Assessment	EG00013 events9 affected1,767 at risk EG00119 events17 affected1,766 at risk
Hypertensive crisis	Vascular disorders	MedDRA 26	Systematic Assessment	EG00010 events7 affected1,767 at risk EG0017 events7 affected1,766 at risk
Hypertensive emergency	Vascular disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypertensive urgency	Vascular disorders	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG0016 events6 affected1,766 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events2 affected1,766 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG00119 events15 affected1,766 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG00023 events22 affected1,767 at risk EG00127 events24 affected1,766 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0005 events4 affected1,767 at risk EG0014 events4 affected1,766 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0009 events7 affected1,767 at risk EG0015 events5 affected1,766 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypotension	Vascular disorders	MedDRA 26	Systematic Assessment	EG00016 events14 affected1,767 at risk EG0017 events7 affected1,766 at risk
Hypothermia	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events4 affected1,766 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ileus	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Impaired healing	General disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Infected fistula	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Infected skin ulcer	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0015 events4 affected1,766 at risk
Infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Infective aortitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Inflammation	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Influenza	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0013 events3 affected1,766 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Insomnia	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intercapillary glomerulosclerosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intermittent claudication	Vascular disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Intervertebral discitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0016 events5 affected1,766 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ischaemia	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00023 events23 affected1,767 at risk EG00136 events34 affected1,766 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Keratinising squamous cell carcinoma of nasopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Keratitis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Klebsiella infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Klebsiella urinary tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Knee operation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Laboratory test abnormal	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Lacunar infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Lacunar stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Large intestine infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG00110 events8 affected1,766 at risk
Laryngeal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0006 events5 affected1,767 at risk EG00111 events11 affected1,766 at risk
Leg amputation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Leriche syndrome	Vascular disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Light chain disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Linear IgA disease	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Liver abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events2 affected1,766 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Liver function test increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Liver injury	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Localised infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Localised oedema	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Loss of consciousness	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0014 events4 affected1,766 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0012 events2 affected1,766 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0016 events6 affected1,766 at risk
Lung adenocarcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events1 affected1,766 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Lymphoedema	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Lymphoplasmacytoid lymphoma/immunocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Macular hole	Eye disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0010 events0 affected1,766 at risk
Macular oedema	Eye disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Maculopathy	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Malaise	General disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0014 events2 affected1,766 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Mental status changes	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0017 events7 affected1,766 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events3 affected1,766 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Metastases to pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Middle cerebral artery stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Migraine	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0012 events2 affected1,766 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Mixed hepatocellular cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Monoplegia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Mucinous breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Mucosal hypertrophy	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0019 events9 affected1,766 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Myelodysplastic syndrome with single lineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Myelopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00015 events15 affected1,767 at risk EG00115 events15 affected1,766 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG00010 events10 affected1,767 at risk EG0013 events3 affected1,766 at risk
Myocarditis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Nausea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG0011 events1 affected1,766 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Necrotising oesophagitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0007 events7 affected1,767 at risk EG0015 events5 affected1,766 at risk
Nephropathy	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Neuroendocrine tumour of the lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Neuroendocrine tumour of the lung metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Neurogenic shock	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Nodal rhythm	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Non-cardiac chest pain	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0018 events8 affected1,766 at risk
Non-small cell lung cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Nosocomial infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ocular ischaemic syndrome	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Oedema	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Oedema peripheral	General disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0014 events4 affected1,766 at risk
Oesophageal fistula	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0003 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Oliguria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Orchitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0013 events3 affected1,766 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG0019 events9 affected1,766 at risk
Osteomyelitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG00011 events9 affected1,767 at risk EG00115 events13 affected1,766 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Otitis media	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pacing induced cardiomyopathy	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pain	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Palpitations	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG0015 events5 affected1,766 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0015 events5 affected1,766 at risk
Panic attack	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Paranoia	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Parapharyngeal space infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Parkinson's disease	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Partial seizures	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Penile abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pericardial calcification	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Pericarditis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0014 events4 affected1,766 at risk
Pericarditis uraemic	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Perinephric abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26	Systematic Assessment	EG00011 events10 affected1,767 at risk EG00129 events19 affected1,766 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events4 affected1,766 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0019 events9 affected1,766 at risk
Peripheral swelling	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Peripheral vascular haematoma	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Peritoneocutaneous fistula	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Peritonitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0017 events7 affected1,766 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0009 events9 affected1,767 at risk EG0016 events5 affected1,766 at risk
Pleurisy viral	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG00070 events66 affected1,767 at risk EG00187 events75 affected1,766 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26	Systematic Assessment	EG0007 events6 affected1,767 at risk EG0014 events4 affected1,766 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG00111 events11 affected1,766 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pneumonia legionella	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pneumonia viral	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Post procedural infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Post-acute COVID-19 syndrome	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Postoperative wound infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0013 events3 affected1,766 at risk
Presbyacusis	Ear and labyrinth disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Presyncope	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Primary amyloidosis	Immune system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Procedural shock	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Proctitis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0009 events9 affected1,767 at risk EG0016 events6 affected1,766 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0003 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Prosthetic cardiac valve malfunction	Product Issues	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Proteinuria	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events4 affected1,766 at risk
Pseudoaneurysm infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pseudohypoaldosteronism	Congenital, familial and genetic disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Psoas abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0006 events6 affected1,767 at risk EG00112 events11 affected1,766 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG00010 events9 affected1,767 at risk EG00114 events14 affected1,766 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pulmonary valve stenosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Pulse abnormal	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pyelonephritis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0014 events4 affected1,766 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0016 events4 affected1,766 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Pyrexia	General disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0017 events7 affected1,766 at risk
Radiculopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Recurrent cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0015 events4 affected1,766 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0012 events2 affected1,766 at risk
Renal cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal colic	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal cyst	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal disorder	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal failure	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG00117 events17 affected1,766 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0009 events9 affected1,767 at risk EG00121 events18 affected1,766 at risk
Renal injury	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal mass	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0011 events1 affected1,766 at risk
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal transplant	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Renal tubular acidosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG00020 events20 affected1,767 at risk EG00112 events11 affected1,766 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retinal artery occlusion	Eye disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retinal detachment	Eye disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Retinal haemorrhage	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Retinal vein occlusion	Eye disorders	MedDRA 26	Systematic Assessment	EG0002 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retinopathy	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retinopathy proliferative	Eye disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0007 events7 affected1,767 at risk EG0014 events4 affected1,766 at risk
Right ventricular failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG0012 events2 affected1,766 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
SARS-CoV-2 sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Sciatica	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Scrotal abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Seizure	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0013 events3 affected1,766 at risk
Seizure like phenomena	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG00020 events17 affected1,767 at risk EG00124 events23 affected1,766 at risk
Septic encephalopathy	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Septic pulmonary embolism	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Septic shock	Infections and infestations	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG00114 events14 affected1,766 at risk
Serous cystadenocarcinoma ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Serratia infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Severe acute respiratory syndrome	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Shock	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Shunt infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Sinusitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Skin infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0015 events5 affected1,766 at risk
Skin lesion removal	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG00113 events7 affected1,766 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0006 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Small intestine neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Small intestine polyp	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Soft tissue infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spinal cord compression	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Spinal decompression	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Spinal epidural haematoma	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Spontaneous bacterial peritonitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Squamous cell carcinoma of the hypopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Staphylococcal infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0013 events3 affected1,766 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Status epilepticus	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Stent-graft endoleak	General disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0012 events2 affected1,766 at risk
Subcapsular renal haematoma	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0017 events5 affected1,766 at risk
Subileus	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Sudden cardiac death	General disorders	MedDRA 26	Systematic Assessment	EG0004 events4 affected1,767 at risk EG0013 events3 affected1,766 at risk
Sudden death	General disorders	MedDRA 26	Systematic Assessment	EG0005 events5 affected1,767 at risk EG00110 events10 affected1,766 at risk
Suicide attempt	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0014 events3 affected1,766 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Superinfection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Suspected COVID-19	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Syncope	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00016 events14 affected1,767 at risk EG0019 events9 affected1,766 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Systolic hypertension	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tension headache	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tethered cord syndrome	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Thalamic infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Thalamic stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Thrombophlebitis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0013 events3 affected1,766 at risk
Tidal volume decreased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Toe amputation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tractional retinal detachment	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Transcatheter aortic valve implantation	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00015 events15 affected1,767 at risk EG00114 events13 affected1,766 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0016 events5 affected1,766 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Traumatic ulcer	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tremor	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Troponin T increased	Investigations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Troponin increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ulcer haemorrhage	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ulcerative gastritis	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ulcerative keratitis	Eye disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0005 events4 affected1,767 at risk EG0013 events2 affected1,766 at risk
Upper motor neurone lesion	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Uraemic gastropathy	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0010 events0 affected1,766 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0010 events0 affected1,766 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0007 events7 affected1,767 at risk EG0010 events0 affected1,766 at risk
Urinary tract candidiasis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Urinary tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG00027 events23 affected1,767 at risk EG00130 events27 affected1,766 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0012 events2 affected1,766 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Urosepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0003 events3 affected1,767 at risk EG0014 events3 affected1,766 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vascular dementia	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0013 events3 affected1,766 at risk
Vascular device infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vascular occlusion	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vascular shunt	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vascular stent occlusion	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vasculitis necrotising	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vasomotor rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0013 events3 affected1,766 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26	Systematic Assessment	EG0008 events8 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vertigo CNS origin	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Viral infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0012 events2 affected1,766 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Vision blurred	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 26	Systematic Assessment	EG0004 events3 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00011 events11 affected1,767 at risk EG0015 events5 affected1,766 at risk
Vulval abscess	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Vulval cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Weight increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
White blood cell count increased	Investigations	MedDRA 26	Systematic Assessment	EG0000 events0 affected1,767 at risk EG0011 events1 affected1,766 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0010 events0 affected1,766 at risk
Wound infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0002 events2 affected1,767 at risk EG0010 events0 affected1,766 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected1,767 at risk EG0011 events1 affected1,766 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
BG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide	Participants received a dose of semaglutide subcutaneously once weekly with dose escalation in every 4 weeks in doses 0.25 mg (weeks 0-3), 0.50 mg (weeks 4-7) until the maintenance dose of 1 mg was reached at week 8 and continued 1 mg dose along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	227	1,767	877	1,767	507	1,767
EG001	Placebo	Participants received placebo matching semaglutide subcutaneously once weekly along with standard of care until end of the study (week 238). Participants were followed up for 5 weeks after end of treatment.	279	1,766	950	1,766	522	1,766