Effect of Liraglutide on Body Weight in Non-diabetic Obes... | NCT01272219

ID	Type	Description	Link
2008-001049-24	EudraCT Number
U1111-1118-7871	Other Identifier	WHO

Label	Type	Intervention Names
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Experimental	Drug: liraglutide
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Experimental	Drug: placebo
Liraglutide Placebo, no Pre-diabetes	Placebo Comparator	Drug: placebo
Liraglutide 3.0mg, Pre-diabetes	Experimental	Drug: liraglutide
Liraglutide Placebo, Pre-diabetes	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).

Measure	Description	Time Frame
Change From Baseline in Fasting Body Weight	The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.	Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At Week 56
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight	Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At 56 weeks
Proportion of Subjects With Onset of Type 2 Diabetes	Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	At 160 weeks

Measure	Description	Time Frame
Change From Baseline in Waist Circumference (cm)	The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

Name	Affiliation	Role
Global Clinical Registry GCR, 1452	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35205-4731	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
27198973	Result	Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19.
27193270	Result	Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	Liraglutide 3.0 mg, no Pre-diabetes	Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Fasting Body Weight

The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).

The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percent change

Week 0, Week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg (56-Week)	Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
OG001	Liraglutide Placebo (56-Week)	Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.

Units	Counts
Participants	OG0002432 OG0011220

Title

Denominators

Categories

Title	Measurements
	OG000-7.98± 6.67 OG001-2.62± 5.74

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	Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.	ANCOVA		<0.0001		Estimated mean difference	-5.39			2-Sided	95	-5.82	-4.95			ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.

Primary

Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.

Posted

Number

percentage of subjects

At Week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg (56-Week)	Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
OG001	Liraglutide Placebo (56-Week)	Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.

Units	Counts
Participants

Primary

Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.

Posted

Number

percentage of subjects

At 56 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg (56-Week)	Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
OG001	Liraglutide Placebo (56-Week)	Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.

Units	Counts
Participants

Primary

Proportion of Subjects With Onset of Type 2 Diabetes

Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.

Posted

Number

Subject

At 160 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg (160-Week)	Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
OG001	Liraglutide Placebo (160-Week)	Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.

Secondary

Change From Baseline in Waist Circumference (cm)

The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).

Posted

Mean

Standard Deviation

Week 0, Week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg (56-Week)	Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
OG001	Liraglutide Placebo (56-Week)	Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.

Units	Counts
Participants

Secondary

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Posted

Mean

Standard Deviation

Week 0, week 160

ID	Title	Description
OG000	Liraglutide 3.0 mg (160-Week)	Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
OG001	Liraglutide Placebo (160-Week)	Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.

Secondary

Pre-diabetes Status After 56 Weeks of Treatment

Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).

Posted

Number

percentage of subjects

Week 0, Week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg (56-Week)	Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
OG001	Liraglutide Placebo (56-Week)	Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.

Units	Counts
Participants

Secondary

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Posted

Number

percentage of subjects

Week 0, week 160

ID	Title	Description
OG000	Liraglutide 3.0 mg (160-Week)	Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
OG001	Liraglutide Placebo (160-Week)	Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.

Secondary

Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Posted

Mean

Standard Deviation

percent change

Week 0, week 160

ID	Title	Description
OG000	Liraglutide 3.0 mg (160-Week)	Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
OG001	Liraglutide Placebo (160-Week)	Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.

Secondary

Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Posted

Number

percentage of subjects

At 160 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg (160-Week)	Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
OG001	Liraglutide Placebo (160-Week)	Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.

Secondary

Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).

Posted

Mean

Standard Deviation

percent change

Week 56, Week 68

ID	Title	Description
OG000	Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
OG001	Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.

Secondary

Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).

Posted

Mean

Standard Deviation

percent change

Week 0, Week 68

ID	Title	Description
OG000	Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
OG001	Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG0030 events0 affected487 at risk
Bandaemia	Blood and lymphatic system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Angina unstable	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Aortic valve disease mixed	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0012 events2 affected755 at risk EG0022 events2 affected957 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cardiomegaly	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Palpitations	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Pericarditis	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Tachycardia	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Multiple endocrine adenomatosis Type I	Congenital, familial and genetic disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Basedow	Endocrine disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Goitre	Endocrine disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Hyperparathyroidism primary	Endocrine disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Toxic nodular goitre	Endocrine disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cataract	Eye disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Retinal detachment	Eye disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0004 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Barrett	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Caecitis	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0012 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Intestinal prolapse	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Pancreatic cyst	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0011 events1 affected755 at risk EG0022 events2 affected957 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Chest discomfort	General disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Chest pain	General disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0021 events1 affected957 at risk EG003
Cyst	General disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Device dislocation	General disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Inflammation	General disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Medical device complication	General disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Metaplasia	General disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA version 15.1	Systematic Assessment	EG0005 events5 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0006 events6 affected1,524 at risk EG0010 events0 affected755 at risk EG0022 events2 affected957 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0009 events9 affected1,524 at risk EG0011 events1 affected755 at risk EG0024 events4 affected957 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG00023 events22 affected1,524 at risk EG0016 events6 affected755 at risk EG0027 events7 affected957 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Hepatic lesion	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Amyloidosis	Immune system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abdominal wall infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abscess neck	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Alveolar osteitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Anal abscess	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Appendicitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Arthritis infective	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Brain abscess	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Breast abscess	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Cellulitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0013 events3 affected755 at risk EG0020 events0 affected957 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Diverticulitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Empyema	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Erysipelas	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0010 events0 affected755 at risk EG0022 events2 affected957 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0022 events2 affected957 at risk EG003
Hepatitis A	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Incision site infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Localised infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Meningitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Oophoritis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Post procedural infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Sepsis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Septic shock	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0003 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Urosepsis	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Vulval abscess	Infections and infestations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Cartilage injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0014 events4 affected755 at risk EG0020 events0 affected957 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0022 events2 affected957 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Stab wound	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Ureteric injury	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Amylase increased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Catheterisation cardiac	Investigations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Lipase increased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Weight decreased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Weight increased	Investigations	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Central obesity	Metabolism and nutrition disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0013 events3 affected755 at risk EG0020 events0 affected957 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0012 events2 affected755 at risk EG0022 events2 affected957 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0013 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0013 events3 affected755 at risk EG0020 events0 affected957 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Dupuytren	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0006 events6 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Joint laxity	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG00014 events12 affected1,524 at risk EG0016 events5 affected755 at risk EG0020 events0 affected957 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0005 events5 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Breast cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Colon cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Haemangioma of bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Hepatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0004 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Mantle cell lymphoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Brain stem infarction	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Convulsion	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Headache	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Intracranial pressure increased	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Migraine	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0011 events1 affected755 at risk EG0022 events2 affected957 at risk EG003
Presyncope	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Spinal cord herniation	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Syncope	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0013 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Depression	Psychiatric disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Bladder prolapse	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
IgA nephropathy	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0004 events4 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0012 events2 affected755 at risk EG0020 events0 affected957 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Adnexa uteri cyst	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Endometrial disorder	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Pelvic adhesions	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Polymenorrhoea	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0003 events3 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0011 events1 affected755 at risk EG0021 events1 affected957 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Cutis laxa	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Excessive skin	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Miscarriage of partner	Social circumstances	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abdominoplasty	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Coronary revascularisation	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0004 events3 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastrectomy	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Gastric bypass	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Heart transplant	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Ligament operation	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Lipectomy	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Mammoplasty	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Obesity surgery	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Rectocele repair	Surgical and medical procedures	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Embolism venous	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypertension	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Hypotension	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0000 events0 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0002 events2 affected1,524 at risk EG0010 events0 affected755 at risk EG0020 events0 affected957 at risk EG003
Varicophlebitis	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0010 events0 affected755 at risk EG0021 events1 affected957 at risk EG003
Varicose vein	Vascular disorders	MedDRA version 15.1	Systematic Assessment	EG0001 events1 affected1,524 at risk EG0011 events1 affected755 at risk EG0020 events0 affected957 at risk EG003

ID	Title	Description
BG000	Liraglutide 3.0 mg, no Pre-diabetes	Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
BG001	Liraglutide Placebo, no Pre-diabetes	Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
BG002	Liraglutide 3.0 mg, Pre-diabetes	Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
BG003	Liraglutide Placebo, Pre-diabetes	Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
BG004	Total	Total of all reporting groups

ID	Term
D009750	Nutritional and Metabolic Diseases
D050177	Overweight
D044343	Overnutrition
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liraglutide 3.0 mg, Pre-diabetes	Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.	230	1,524	1,342	1,524
EG001	Liraglutide Placebo, Pre-diabetes	Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.	96	755	586	755
EG002	Liraglutide 3.0 mg, no Pre-diabetes	Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.	59	957	843	957
EG003	Liraglutide Placebo, no Pre-diabetes	Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.	19	487	345	487