A Long-term Safety Study of Orforglipron (LY3502970) in P... | NCT06010004

ID	Type	Description	Link
J2A-JE-GZPE	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
3 mg Orforglipron	Experimental	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	Drug: Orforglipron
12 mg Orforglipron	Experimental	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	Drug: Orforglipron
36 mg Orforglipron	Experimental	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.	Drug: Orforglipron

Name	Type	Description	Arm Group Labels	Other Names
Orforglipron	Drug	Administered orally	12 mg Orforglipron 3 mg Orforglipron 36 mg Orforglipron

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.	Baseline to Week 54

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.	Baseline, Week 52
Percentage of Participants Who Achieved HbA1c <7.0%

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

Facility	Status	City	State	ZIP	Country	Contacts
Nakayama Clinic		Nagoya	Aichi-ken	456-0058	Japan
Shinkashiwa Clinic

Label	URL
A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)	View source

ID	Title	Description
FG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
FG001	12 mg Orforglipron

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 11, 2024	May 26, 2026

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 With Treatment Emergent Adverse Events (TEAEs)

A TEAE was defined as any adverse event that began on or after the first dose of study drug or began before the first dose of study drug and worsened on or after the first dose of study drug.

All participants who were randomized and received at least one dose of the study drug.

Posted

Count of Participants

Participants

Baseline to Week 54

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Units	Counts
Participants	OG000132 OG001135 OG002134

Title

Denominators

Categories

Title	Measurements
	OG000107 OG001114 OG002118

Secondary

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.

All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Percentage of Participants Who Achieved HbA1c <7.0%

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.

All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron

Secondary

Percentage of Participants Who Achieved HbA1c ≤6.5%

All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron

Secondary

Percentage of Participants Who Achieved HbA1c <5.7%

All participants who were randomized and had non-missing HbA1c values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron

Secondary

Change From Baseline in Fasting Serum Glucose

All participants who were randomized and had non-missing fasting serum glucose values at baseline and week 52.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Change From Baseline in Body Weight

All participants who were randomized and had non-missing body weight values at baseline and week 52.

Posted

Least Squares Mean

Standard Error

kilogram (kg)

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥5% From Baseline

The reported values represent model-based estimates. The Mean (SE) is an estimated values from a logistic regression using imputed data by multiple imputation, with percentages derived by combining proportion of participants achieving target in imputed data sets using Rubin's rule.

All participants who were randomized and had non-missing body weight values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥10% From Baseline

All participants who were randomized and had non-missing body weight values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Percentage of Participants Who Achieved Weight Loss of ≥15% From Baseline

All participants who were randomized and had non-missing body weight values at baseline and week 52.

Posted

Mean

Standard Error

percentage of participants

Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Change From Baseline in Waist Circumference

All participants who were randomized and had non-missing waist circumference values at baseline and week 52.

Posted

Least Squares Mean

Standard Error

centimeter (cm)

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Change From Baseline in Body Mass Index (BMI)

All participants who were randomized and had non-missing BMI values at baseline and week 52.

Posted

Least Squares Mean

Standard Error

kilogram per square meter (kg/m^2)

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Secondary

Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)

SMBG is measured using a glucometer. The SMBG profiles will consist of the following 7-point measurements obtained on a single day:

before 3 main meals,
approximately 2 hours after 3 main meals, and
at bedtime

Daily average glucose was calculated as the mean of 7 time point specific averages obtained from up to 2 non-consecutive SMBG profiles within week 52.

All participants who were randomized and had non-missing 7-Point SMBG values at baseline and week 52.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 52

ID	Title	Description
OG000	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
OG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
OG002	36 mg Orforglipron

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Arrhythmia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Cardiac failure	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Palpitations	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Thyroid mass	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0022 events1 affected134 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Diabetic retinopathy	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected132 at risk EG0014 events4 affected135 at risk EG0026 events6 affected134 at risk
Dry eye	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Epiretinal membrane	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Eye discharge	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Eye inflammation	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Glaucoma	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Lacrimation increased	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Macular degeneration	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Macular oedema	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Ocular hypertension	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Photophobia	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Retinal degeneration	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Retinal haemorrhage	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Vision blurred	Eye disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00011 events10 affected132 at risk EG0017 events6 affected135 at risk EG00210 events7 affected134 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected132 at risk EG00110 events9 affected135 at risk EG0025 events5 affected134 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0023 events3 affected134 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected132 at risk EG0015 events5 affected135 at risk EG0023 events3 affected134 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0014 events4 affected135 at risk EG0021 events1 affected134 at risk
Colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00023 events22 affected132 at risk EG00142 events41 affected135 at risk EG00245 events39 affected134 at risk
Dental caries	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0014 events4 affected135 at risk EG0024 events4 affected134 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00012 events12 affected132 at risk EG00120 events16 affected135 at risk EG00224 events16 affected134 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected132 at risk EG00111 events10 affected135 at risk EG00223 events18 affected134 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Eructation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0017 events7 affected135 at risk EG0028 events8 affected134 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0023 events2 affected134 at risk
Flatulence	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0022 events1 affected134 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0011 events1 affected135 at risk EG0022 events2 affected134 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00011 events11 affected132 at risk EG0015 events5 affected135 at risk EG0027 events7 affected134 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0012 events2 affected135 at risk EG0024 events4 affected134 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Leukoplakia oral	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00018 events17 affected132 at risk EG00135 events26 affected135 at risk EG00238 events37 affected134 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Toothache	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00040 events17 affected132 at risk EG00140 events15 affected135 at risk EG00235 events17 affected134 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Chest discomfort	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Chills	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Facial pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0023 events3 affected134 at risk
General physical health deterioration	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Generalised oedema	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Injection site pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events1 affected135 at risk EG0020 events0 affected134 at risk
Malaise	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0026 events6 affected134 at risk
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0013 events2 affected135 at risk EG0020 events0 affected134 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected132 at risk EG0015 events5 affected135 at risk EG0022 events2 affected134 at risk
Swelling face	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Thirst	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Vessel puncture site bruise	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Hepatic calcification	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hyperplastic cholecystopathy	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Metabolic dysfunction-associated liver disease	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Seasonal allergy	Immune system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Bronchitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0014 events4 affected135 at risk EG0021 events1 affected134 at risk
Chronic sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Conjunctivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Coronavirus infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected132 at risk EG0010 events0 affected135 at risk EG0023 events3 affected134 at risk
Covid-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00012 events12 affected132 at risk EG00111 events11 affected135 at risk EG00211 events11 affected134 at risk
Cystitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected132 at risk EG0011 events1 affected135 at risk EG0026 events5 affected134 at risk
Dermatophytosis of nail	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0022 events2 affected134 at risk
Enteritis infectious	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Folliculitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Gastroenteritis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0015 events4 affected135 at risk EG0022 events2 affected134 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Gingivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Helicobacter infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Herpes zoster	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0011 events1 affected135 at risk EG0023 events3 affected134 at risk
Influenza	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected132 at risk EG0012 events2 affected135 at risk EG0025 events5 affected134 at risk
Nasopharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG00026 events23 affected132 at risk EG00138 events30 affected135 at risk EG00229 events22 affected134 at risk
Otitis externa	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Otitis media	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Otitis media acute	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Paronychia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Parotitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Periodontitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Pharyngitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0006 events5 affected132 at risk EG0014 events4 affected135 at risk EG0023 events3 affected134 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Purulence	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Rhinitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Sinusitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0013 events3 affected135 at risk EG0020 events0 affected134 at risk
Tinea pedis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0023 events3 affected134 at risk
Tonsillitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Viral diarrhoea	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected38 at risk EG0020 events0 affected41 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Bite	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Chillblains	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0014 events3 affected135 at risk EG0020 events0 affected134 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0022 events2 affected134 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0023 events1 affected134 at risk
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0025 events4 affected134 at risk
Amylase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0011 events1 affected135 at risk EG0027 events3 affected134 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Blood uric acid increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Faecal occult blood positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Heart rate increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Hepatic enzyme increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Influenza a virus test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Lipase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0007 events7 affected132 at risk EG0013 events3 affected135 at risk EG0028 events7 affected134 at risk
Pancreatic enzymes increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Platelet count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Prostatic specific antigen increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected97 at risk EG0020 events0 affected93 at risk
Sars-cov-2 test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Urinary occult blood positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Urine ketone body present	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0023 events3 affected134 at risk
White blood cell count increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0016 events6 affected135 at risk EG00213 events13 affected134 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Gout	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected132 at risk EG0015 events5 affected135 at risk EG0024 events4 affected134 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0009 events9 affected132 at risk EG0017 events5 affected135 at risk EG0028 events8 affected134 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Chondrodynia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0022 events2 affected134 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0013 events3 affected135 at risk EG0029 events6 affected134 at risk
Dizziness postural	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0013 events3 affected135 at risk EG0020 events0 affected134 at risk
Dysgeusia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Head discomfort	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0023 events2 affected134 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected132 at risk EG0015 events5 affected135 at risk EG00211 events6 affected134 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Paraesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events1 affected134 at risk
Sciatica	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Taste disorder	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0013 events3 affected135 at risk EG0022 events2 affected134 at risk
Ulnar tunnel syndrome	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Abulia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Depression	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Discouragement	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0025 events2 affected134 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dysuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Haematuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Renal cyst	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0011 events1 affected135 at risk EG0022 events1 affected134 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Urinary retention	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected97 at risk EG0021 events1 affected93 at risk
Mammary duct ectasia	Reproductive system and breast disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected132 at risk EG0012 events2 affected135 at risk EG0023 events3 affected134 at risk
Cough variant asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected132 at risk EG0013 events3 affected135 at risk EG0020 events0 affected134 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0013 events3 affected135 at risk EG0020 events0 affected134 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Diabetic bullosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0013 events3 affected135 at risk EG0022 events2 affected134 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0022 events2 affected134 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0022 events2 affected134 at risk
Skin discomfort	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0023 events2 affected134 at risk
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0021 events1 affected134 at risk
Bladder catheterisation	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0020 events0 affected134 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Laser surgery	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Radical prostatectomy	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected97 at risk EG0021 events1 affected93 at risk
Removal of foreign body	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0012 events2 affected135 at risk EG0020 events0 affected134 at risk
Retinal laser coagulation	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0004 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Suture insertion	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0012 events2 affected135 at risk EG0021 events1 affected134 at risk
Tumour excision	Surgical and medical procedures	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0010 events0 affected135 at risk EG0021 events1 affected134 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected132 at risk EG0010 events0 affected135 at risk EG0020 events0 affected134 at risk
Hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected132 at risk EG0011 events1 affected135 at risk EG0022 events2 affected134 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected132 at risk EG0010 events0 affected135 at risk EG0026 events6 affected134 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	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
BG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
BG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.
BG003	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	3 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.	0	132	4	132	106	132
EG001	12 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.	0	135	3	135	114	135
EG002	36 mg Orforglipron	Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.	1	134	6	134	118	134