A Study of Tirzepatide (LY3298176) in Participants With O... | NCT04184622

ID	Type	Description	Link
I8F-MC-GPHK	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Placebo
5 mg Tirzepatide	Experimental	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	Drug: Tirzepatide
10 mg Tirzepatide	Experimental	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Body Weight (Primary Treatment Period)	Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)	Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.	Week 72

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period	LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.	Baseline, Week 20

Eligibility Module

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
Cahaba Research		Pelham	Alabama	35124	United States
Perseverance Research Center

PubMed Identifier	Type	Citation	Retractions
42348366	Derived	Kokkinos A, Thethi T, Lee CJ, Neff LM, Stefanski A, Cao D, Rodriguez A, Bartee A. Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials. Diabetes Obes Metab. 2026 Jun 25. doi: 10.1111/dom.71009. Online ahead of print.
42233927	Derived

Label	URL
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.

Periods

Title

Milestones

Reasons Not Completed

Primary Treatment Period

Type	Comment	Milestone Data
STARTED	Participants with normoglycemia or prediabetes at the time of randomization were eligible to enter this primary treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 4, 2021	Jan 19, 2023

Arm/Group Information

ID	Title	Description
BG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
BG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
BG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.
BG003	15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.4± 12.5 BG00145.6± 12.7 BG00244.7± 12.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000436 BG001426 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00058 BG00156 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00093 BG00190 BG002

Baseline Body Weight

Mean

Standard Deviation

kilograms (kg)

Title

Denominators

Categories

Title	Measurements
	BG000104.9± 21.37 BG001102.88± 20.71 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in Body Weight (Primary Treatment Period)

Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.
OG003	15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72.

Units	Counts
Participants	OG000635 OG001623 OG002629 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.4± 0.40 OG001-16.0± 0.39 OG002-21.4± 0.39 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Least Square (LS) Mean Difference (Net)	-13.5			2-Sided	95	-14.6	-12.5					Superiority
OG000 OG002		Mixed Models Analysis		<0.001

Primary

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)

Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% Body Weight Reduction, excluding data after prematurely stopping study drug.

Posted

Number

Percentage of Participants

Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide.

Posted

Least Squares Mean

Standard Error

kilograms

Baseline, Week 20

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg or 15mg, which was then maintained up to week 72.

Secondary

Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)

Percentage of Participants who Achieve ≥10% Body Weight Reduction

All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% Body Weight Reduction, excluding data after prematurely stopping study drug.

Posted

Number

Percentage of Participants

Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)

Percentage of participants who achieve ≥15% body weight reduction.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥15% body weight reduction, excluding data after prematurely stopping study drug.

Posted

Number

Percentage of Participants

Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)

Percentage of participants who achieve ≥20% body weight reduction.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥20% Body Weight Reduction, excluding data after prematurely stopping study drug.

Posted

Number

Percentage of Participants

Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Change From Baseline in Waist Circumference (Primary Treatment Period)

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline weight circumference value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

centimeters

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period

The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline SF-36v2 value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 10 mg and 15 mg tirzepatide.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001

Secondary

Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had a baseline and at least one post-baseline triglyceride value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.

Secondary

Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72.

Units	Counts

Secondary

Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline total cholesterol HDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72.

Units

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline SBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Least Squares Mean

Standard Error

millimeter of mercury (mmHg)

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.

Secondary

Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had a baseline and at least one post-baseline fasting insulin value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.

Secondary

Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

LS Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, treatment, time, treatment*time (Type III sum of squares) in the model.

Participants with prediabetes at randomization who received at least one dose of study drug and had baseline and at least one post-baseline body weight value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

percent change

Baseline, Week 176

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176.

Secondary

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.

Time to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.

Participants with prediabetes at randomization who received at least one dose of study drug (including the censored participants). Number of participants censored in Placebo = 236, Pooled 5 mg/10 mg/15 mg Tirzepatide = 753.

Posted

Number

Percentage of Participants

Baseline through Week 176

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5mg,10 mg or 15mg, tirzepatide dose SC QW until week 176.

Secondary

Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)

The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported.

Posted

Number

Percentage of Participants

Baseline through Week 193

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193).
OG001

Secondary

Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

kilograms per meter squared (kg/m^2)

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period

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 calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline HbA1c value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide

Secondary

Change From Baseline in Fasting Glucose (Primary Treatment Period)

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline fasting glucose value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

milligram per deciliter (mg/dL)

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.

Secondary

Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had a baseline and at least one post-baseline LDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg,10 mg or 15 mg, which was then maintained up to week 72.

Units	Counts

Secondary

Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline VLDL value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg,10 mg or 15 mg, which was then maintained up to week 72.

Units	Counts

Secondary

Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline free fatty acids value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Mean

Standard Error

percent change

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, 10 mg or 15 mg, which was then maintained up to week 72.

Units	Counts

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period

LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline DBP value, excluding data after prematurely stopping study drug. This analysis was planned to measure the outcome for pooled 5 mg, 10 mg and 15 mg tirzepatide.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	Pooled 5 mg/10 mg/15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5mg,10 mg or 15mg, which was then maintained up to week 72.

Secondary

Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)

Percentage of Participants Who Achieve ≥5% Body Weight Reduction.

Participants with prediabetes at randomization who received at least one dose of study drug and had baseline and at least one post-baseline value for body weight, excluding data after prematurely stopping study drug.

Posted

Number

Percentage of Participants

Week 176

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176.
OG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176.

Secondary

Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 (Primary Treatment Period)

The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcomes (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

All participants who received at least one dose of study drug and had baseline and at least one post-baseline IWQOL-Lite CT value, excluding data after prematurely stopping study drug.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Week 72

ID	Title	Description
OG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks.
OG001	5 mg Tirzepatide

Secondary

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide (Primary Treatment Period)

PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.

All randomly assigned participants who are exposed to at least one dose of study drug who had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanograms*hours per milliliter (ng*h/mL)

Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

ID	Title	Description
OG000	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72.
OG001	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72.
OG002	15 mg Tirzepatide

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	4	643	53	643	315	643
EG001	5 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	4	630	57	630	443	630
EG002	10 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	3	636	60	636	451	636
EG003	15 mg Tirzepatide	Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72. Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176. Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.	2	630	50	630	429	630

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG0030 events0 affected630 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Wolff-parkinson-white syndrome	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Ear canal stenosis	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Cataract	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0013 events3 affected630 at risk EG0020 events0 affected636 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0012 events2 affected630 at risk EG0020 events0 affected636 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Biloma	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0022 events2 affected636 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0012 events2 affected630 at risk EG0023 events3 affected636 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected643 at risk EG0013 events3 affected630 at risk EG0026 events6 affected636 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Sphincter of oddi dysfunction	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Anal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Appendicitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected643 at risk EG0014 events4 affected630 at risk EG0020 events0 affected636 at risk EG003
Bacterial colitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Cellulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Coronavirus infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Coronavirus pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0006 events6 affected643 at risk EG0012 events2 affected630 at risk EG0025 events5 affected636 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected643 at risk EG0017 events7 affected630 at risk EG0024 events4 affected636 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0022 events1 affected636 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Peritoneal tuberculosis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0022 events1 affected636 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Pneumonia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0013 events3 affected630 at risk EG0021 events1 affected636 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Septic shock	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Central cord syndrome	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Suture rupture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Sars-cov-2 test positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Adenocarcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Adenosquamous carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0011 events1 affected426 at risk EG0020 events0 affected427 at risk EG003
Gallbladder cancer stage iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Non-small cell lung cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0011 events1 affected426 at risk EG0020 events0 affected427 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Ovarian germ cell endodermal sinus tumour stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0011 events1 affected426 at risk EG0020 events0 affected427 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected204 at risk EG0020 events0 affected209 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected204 at risk EG0020 events0 affected209 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Renal cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Brain oedema	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Idiopathic generalised epilepsy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0022 events2 affected636 at risk EG003
Multiple sclerosis relapse	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Occipital neuralgia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0022 events1 affected636 at risk EG003
Seizure	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Thalamus haemorrhage	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Vertebrobasilar stroke	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0011 events1 affected426 at risk EG0020 events0 affected427 at risk EG003
Placenta accreta	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0011 events1 affected426 at risk EG0020 events0 affected427 at risk EG003
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Device dislocation	Product Issues	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Adjustment disorder with mixed anxiety and depressed mood	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Bulimia nervosa	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Major depression	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Substance abuse	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0022 events1 affected636 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected643 at risk EG0012 events2 affected630 at risk EG0021 events1 affected636 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0021 events1 affected427 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0021 events1 affected427 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Uterine fibrosis	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0021 events1 affected427 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected436 at risk EG0010 events0 affected426 at risk EG0021 events1 affected427 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected436 at risk EG0010 events0 affected426 at risk EG0020 events0 affected427 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0011 events1 affected630 at risk EG0020 events0 affected636 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected643 at risk EG0011 events1 affected630 at risk EG0021 events1 affected636 at risk EG003
Homicide	Social circumstances	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Cholecystectomy	Surgical and medical procedures	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Parathyroidectomy	Surgical and medical procedures	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Thyroidectomy	Surgical and medical procedures	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Hypertensive urgency	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003
Hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected643 at risk EG0010 events0 affected630 at risk EG0021 events1 affected636 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected643 at risk EG0010 events0 affected630 at risk EG0020 events0 affected636 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00028 events24 affected643 at risk EG00152 events38 affected630 at risk EG00256 events38 affected636 at risk EG00362 events33 affected630 at risk
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00049 events38 affected643 at risk EG001129 events113 affected630 at risk EG002148 events117 affected636 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00090 events51 affected643 at risk EG001209 events128 affected630 at risk EG002281 events143 affected636 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00034 events31 affected643 at risk EG00188 events59 affected630 at risk EG00282 events64 affected636 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events4 affected643 at risk EG00132 events24 affected630 at risk EG00237 events35 affected636 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00017 events16 affected643 at risk EG00135 events31 affected630 at risk EG00229 events28 affected636 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG000103 events63 affected643 at risk EG001404 events160 affected630 at risk EG002540 events217 affected636 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00013 events12 affected643 at risk EG00182 events58 affected630 at risk EG002122 events74 affected636 at risk EG003
Injection site reaction	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected643 at risk EG001175 events18 affected630 at risk EG002229 events36 affected636 at risk EG003
Covid-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG000117 events106 affected643 at risk EG001137 events127 affected630 at risk EG002141 events128 affected636 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00036 events30 affected643 at risk EG00139 events32 affected630 at risk EG00246 events30 affected636 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG00047 events38 affected643 at risk EG00137 events30 affected630 at risk EG00242 events38 affected636 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00025 events22 affected643 at risk EG00165 events60 affected630 at risk EG00287 events75 affected636 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG00036 events36 affected643 at risk EG0015 events5 affected630 at risk EG0029 events9 affected636 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00024 events22 affected643 at risk EG00133 events32 affected630 at risk EG00228 events20 affected636 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG00029 events26 affected643 at risk EG00136 events31 affected630 at risk EG00234 events30 affected636 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00017 events16 affected643 at risk EG00136 events31 affected630 at risk EG00246 events37 affected636 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00053 events47 affected643 at risk EG00157 events47 affected630 at risk EG00269 events51 affected636 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0007 events7 affected643 at risk EG00135 events33 affected630 at risk EG00233 events32 affected636 at risk EG003

ID	Term
D050177	Overweight
D009765	Obesity
D009748	Nutrition Disorders
D011236	Prediabetic State

ID	Term
D044343	Overnutrition
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System 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