A Study of Tirzepatide (LY3298176) Once a Week Versus Ins... | NCT03730662

ID	Type	Description	Link
I8F-MC-GPGM	Other Identifier	Eli Lilly and Company
2018-002618-11	EudraCT Number

Label	Type	Description	Intervention Names
5 mg Tirzepatide	Experimental	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	Drug: Tirzepatide
10 mg Tirzepatide	Experimental	10 mg tirzepatide administered SC once a week.	Drug: Tirzepatide
15 mg Tirzepatide	Experimental	15 mg tirzepatide administered SC once a week.	Drug: Tirzepatide
Insulin Glargine	Active Comparator	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.	Drug: Insulin Glargine

Name	Type	Description	Arm Group Labels	Other Names
Tirzepatide	Drug	Administered SC.	10 mg Tirzepatide 15 mg Tirzepatide 5 mg Tirzepatide

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).	Baseline, Week 52

Measure	Description	Time Frame
Change From Baseline in HbA1c (5 mg)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

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
Advanced Research Center		Anaheim	California	92805	United States
Valley Clinical Trials, Inc.

PubMed Identifier	Type	Citation	Retractions
39531161	Derived	De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.
37668888

Label	URL
A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk	View source

ID	Title	Description
FG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
FG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 10, 2020	Aug 19, 2021

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 Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 52

ID	Title	Description
OG000	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG001	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
OG002	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.

Units	Counts
Participants	OG000289 OG001291 OG002887

Title

Denominators

Categories

Title	Measurements
	OG000-2.43± 0.053 OG001-2.58± 0.053 OG002-1.44± 0.030

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		<0.001		Mean Difference (Net)	-0.99			2-Sided	97.5	-1.13	-0.86					Non-Inferiority	Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides >90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia ("efficacy" estimand).

Secondary

Change From Baseline in HbA1c (5 mg)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.

Units	Counts

Secondary

Change From Baseline in Body Weight

LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

Posted

Least Squares Mean

Standard Error

Kilograms (kg)

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
OG003	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.

Secondary

Percentage of Participants With HbA1c of <7.0%

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
OG003	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.

Secondary

Change From Baseline in Fasting Serum Glucose

Posted

Least Squares Mean

Standard Error

milligram per Deciliter (mg/dL)

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
OG003	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.

Secondary

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

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

All randomized participants who received at least one dose of study drug, excluding participants discontinuing study drug due to inadvertent enrollment

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
OG003

Secondary

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide

Pharmacokinetic samples were collected from atleast the first 150 participants at each Tirzepatide dose, all participants aged ≥70 years, and all participants with severe renal impairment or end-stage renal disease (ESRD) (estimated glomerular filtration rate [eGFR] <30 mL/min)

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanograms per millilitre per hour

1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.

Secondary

Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia

The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL (<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (<=8.5%, >8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable

All randomized participants who received at least one dose of study drug, excluding participants hypoglycemic events occurring after initiation of a new antihyperglycemic therapy

Posted

Mean

Standard Error

Episodes/participant/365.25 days

Baseline through Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
OG002

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG0033 events3 affected1,000 at risk
Bicytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected329 at risk EG0017 events7 affected328 at risk EG0023 events3 affected338 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected328 at risk EG0021 events1 affected338 at risk EG003
Aortic valve sclerosis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected328 at risk EG0021 events1 affected338 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected328 at risk EG0022 events2 affected338 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected329 at risk EG0014 events4 affected328 at risk EG0023 events2 affected338 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Myocarditis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Ventricular dysfunction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected198 at risk EG0010 events0 affected209 at risk EG0020 events0 affected203 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Gastric polyps	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0022 events2 affected338 at risk EG003
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Death	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Necrosis	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Sudden cardiac death	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Sudden death	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Asymptomatic covid-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Covid-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0012 events2 affected328 at risk EG0022 events2 affected338 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0016 events6 affected328 at risk EG0023 events3 affected338 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Erysipelas	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Fournier's gangrene	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Hiv infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Liver abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Nosocomial infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected328 at risk EG0022 events2 affected338 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Septic shock	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0021 events1 affected338 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Urosepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0011 events1 affected328 at risk EG0022 events2 affected338 at risk EG003
Wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Nerve injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0021 events1 affected338 at risk EG003
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Blood lactic acid increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Influenza a virus test positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0025 events3 affected338 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Breast cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Nasopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0010 events0 affected119 at risk EG0021 events1 affected135 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected198 at risk EG0010 events0 affected209 at risk EG0021 events1 affected203 at risk EG003
Renal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cerebellar stroke	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Coma	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Cranial nerve disorder	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Guillain-barre syndrome	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hemiplegia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0014 events4 affected328 at risk EG0021 events1 affected338 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Myelopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Thalamic infarction	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected328 at risk EG0021 events1 affected338 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Bladder mass	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Urinary bladder polyp	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected131 at risk EG0010 events0 affected119 at risk EG0020 events0 affected135 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Coronary artery bypass	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Intervertebral disc operation	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Spinal fusion surgery	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Iliac artery stenosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected328 at risk EG0021 events1 affected338 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected328 at risk EG0020 events0 affected338 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0021 events1 affected338 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0010 events0 affected328 at risk EG0020 events0 affected338 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D003920	Diabetes Mellitus
D009750	Nutritional and Metabolic Diseases

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides

ID	Title	Description
BG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
BG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.
BG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.
BG003	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.
BG004	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	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	15	329	48	329	112	329
EG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.	2	328	54	328	158	328
EG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.	8	338	41	338	184	338
EG003	Insulin Glargine	Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG <100 mg/dL, following a treat-to-target (TTT) algorithm.	35	1,000	193	1,000	192	1,000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00017 events17 affected329 at risk EG00115 events14 affected328 at risk EG00214 events14 affected338 at risk EG0035 events5 affected1,000 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00068 events41 affected329 at risk EG001128 events65 affected328 at risk EG002118 events74 affected338 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00023 events18 affected329 at risk EG00136 events27 affected328 at risk EG00236 events26 affected338 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000104 events39 affected329 at risk EG00191 events53 affected328 at risk EG002157 events76 affected338 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00018 events16 affected329 at risk EG00143 events27 affected328 at risk EG00262 events29 affected338 at risk EG003
Covid-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00014 events13 affected329 at risk EG00112 events12 affected328 at risk EG00217 events17 affected338 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00011 events10 affected329 at risk EG00117 events16 affected328 at risk EG00219 events16 affected338 at risk EG003
Lipase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00011 events10 affected329 at risk EG00115 events13 affected328 at risk EG00225 events21 affected338 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00036 events29 affected329 at risk EG00146 events36 affected328 at risk EG00243 events35 affected338 at risk EG003