A Long-term Safety Study of Tirzepatide (LY3298176) in Pa... | NCT03861039

ID	Type	Description	Link
I8F-JE-GPGP	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
5 mg Tirzepatide	Experimental	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	Drug: Tirzepatide Drug: Oral antihyperglycemic medication (OAM)
10 mg Tirzepatide	Experimental	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	Drug: Tirzepatide Drug: Oral antihyperglycemic medication (OAM)
15 mg Tirzepatide	Experimental	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	Drug: Tirzepatide Drug: Oral antihyperglycemic medication (OAM)

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
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	An SAE is any AE from this study that results in one of the following outcomes: Death Initial or prolonged inpatient hospitalization A life-threatening experience (that is, immediate risk of dying) Persistent or significant disability/incapacity Congenital anomaly/birth defect. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Baseline through Week 52

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	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 + oral antihyperglycemic medication (OAM) Group 1 + 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
Akaicho Clinic		Chiba	Chiba	260 0804	Japan
Kashiwa hospital

PubMed Identifier	Type	Citation	Retractions
40711720	Derived	Mimura H, Oura T, Chin R, Hirase T, Shimono D. Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis. Diabetes Ther. 2025 Sep;16(9):1871-1885. doi: 10.1007/s13300-025-01775-y. Epub 2025 Jul 25.
35914542	Derived

Label	URL
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes	View source

ID	Title	Description
FG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2019	Dec 9, 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

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

An SAE is any AE from this study that results in one of the following outcomes:

Death
Initial or prolonged inpatient hospitalization
A life-threatening experience (that is, immediate risk of dying)
Persistent or significant disability/incapacity
Congenital anomaly/birth defect.
Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require.

A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

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

Posted

Count of Participants

Participants

Baseline through Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Units	Counts
Participants	OG000148 OG001147 OG002148

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0021

Secondary

Change From Baseline in Hemoglobin A1c (HbA1c)

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 + oral antihyperglycemic medication (OAM) Group 1 + 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.

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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002

Secondary

Percentage of Participants Who Achieve HbA1c <7%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Change From Baseline in Fasting Serum Glucose

Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.

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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide

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 analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (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.

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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002

Secondary

Change From Baseline in Body Weight

LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.

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. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

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

Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline

All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.

Posted

Number

percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Change From Baseline in Fasting Insulin

LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.

Posted

Least Squares Mean

Standard Error

picomol per liter (pmol/L)

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Change From Baseline in Fasting C-Peptide

LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.

Posted

Least Squares Mean

Standard Error

micrograms/litre (ug/L)

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)

The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).

LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.

Posted

Least Squares Mean

Standard Error

percentage of HOMA-2B

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Change From Baseline in HOMA-2S (Insulin)

LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.

Posted

Least Squares Mean

Standard Error

Percentage of HOMA-2S

Baseline, Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy

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.

All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.

Posted

Count of Participants

Participants

Baseline through Week 56

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Secondary

Number of Participants With Anti-Tirzepatide Antibodies

Number of Participants with Anti-Tirzepatide Antibodies

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

Posted

Count of Participants

Participants

Baseline through Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
OG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Cataract	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0021 events1 affected148 at risk
Eyelid ptosis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Macular fibrosis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Diabetic gangrene	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Pneumonia legionella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Intra-cerebral aneurysm operation	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Bundle branch block right	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0013 events3 affected147 at risk EG0021 events1 affected148 at risk
Blepharitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Cataract	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Corneal leukoma	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Diabetic retinopathy	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0013 events3 affected147 at risk EG0021 events1 affected148 at risk
Dry eye	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Eczema eyelids	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Glaucoma	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Iridocyclitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Maculopathy	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events1 affected148 at risk
Ocular hypertension	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Swelling of eyelid	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Vitreous floaters	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00010 events9 affected148 at risk EG0019 events7 affected147 at risk EG00210 events8 affected148 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0006 events5 affected148 at risk EG0017 events6 affected147 at risk EG0027 events6 affected148 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0013 events2 affected147 at risk EG0022 events2 affected148 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected148 at risk EG0014 events4 affected147 at risk EG0025 events5 affected148 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00012 events12 affected148 at risk EG00121 events20 affected147 at risk EG00224 events22 affected148 at risk
Dental caries	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected148 at risk EG0012 events1 affected147 at risk EG0020 events0 affected148 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00024 events11 affected148 at risk EG00140 events20 affected147 at risk EG00228 events20 affected148 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0006 events6 affected148 at risk EG00119 events11 affected147 at risk EG0026 events5 affected148 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Eructation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0021 events1 affected148 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0012 events2 affected147 at risk EG0023 events3 affected148 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0024 events4 affected148 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected148 at risk EG0016 events6 affected147 at risk EG0024 events4 affected148 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00060 events14 affected148 at risk EG00135 events20 affected147 at risk EG00251 events40 affected148 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Parotid gland enlargement	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0005 events4 affected148 at risk EG00113 events11 affected147 at risk EG00223 events15 affected148 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Chest discomfort	General disorders	MedDRA 23.1	Systematic Assessment	EG0004 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0024 events2 affected148 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0012 events2 affected147 at risk EG0024 events3 affected148 at risk
Injection site haemorrhage	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events1 affected148 at risk
Injection site reaction	General disorders	MedDRA 23.1	Systematic Assessment	EG0007 events4 affected148 at risk EG00125 events3 affected147 at risk EG00272 events4 affected148 at risk
Malaise	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0014 events3 affected147 at risk EG0026 events6 affected148 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Fatty liver alcoholic	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Adenoviral conjunctivitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Cystitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0013 events3 affected147 at risk EG0026 events2 affected148 at risk
Dermatitis infected	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Empyema	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0020 events0 affected148 at risk
Enterocolitis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Folliculitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Furuncle	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0009 events7 affected148 at risk EG0015 events5 affected147 at risk EG0024 events4 affected148 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Gingivitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Helicobacter infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hepatitis e	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Herpes simplex	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Herpes virus infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Herpes zoster	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0014 events4 affected147 at risk EG0023 events3 affected148 at risk
Hordeolum	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0023 events2 affected148 at risk
Infected dermal cyst	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Nasal vestibulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00034 events28 affected148 at risk EG00126 events20 affected147 at risk EG00237 events27 affected148 at risk
Oral herpes	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Paronychia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Parotitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Periodontitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0013 events3 affected147 at risk EG0022 events2 affected148 at risk
Rhinitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Tinea pedis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Tonsillitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Tracheobronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Varicella	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0012 events2 affected34 at risk EG0021 events1 affected44 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0013 events3 affected147 at risk EG0020 events0 affected148 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected148 at risk EG0013 events2 affected147 at risk EG0021 events1 affected148 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0013 events3 affected147 at risk EG0020 events0 affected148 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Amylase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected148 at risk EG0013 events3 affected147 at risk EG0022 events2 affected148 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0023 events3 affected148 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Blood calcitonin increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Blood creatinine increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Blood pressure decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Electrocardiogram st segment depression	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Heart rate increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Helicobacter test positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hepatic enzyme increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0023 events1 affected148 at risk
Lipase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0005 events4 affected148 at risk EG0014 events4 affected147 at risk EG0029 events9 affected148 at risk
Occult blood	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Occult blood positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Salmonella test positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0018 events8 affected147 at risk EG0026 events6 affected148 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00011 events11 affected148 at risk EG00118 events15 affected147 at risk EG00219 events18 affected148 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hypercalcitoninaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0012 events2 affected147 at risk EG0024 events4 affected148 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected148 at risk EG0018 events8 affected147 at risk EG0020 events0 affected148 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events1 affected147 at risk EG0021 events1 affected148 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Nodal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0022 events2 affected148 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0012 events2 affected147 at risk EG0022 events2 affected148 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0020 events0 affected148 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0020 events0 affected148 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected34 at risk EG0021 events1 affected44 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0013 events1 affected147 at risk EG0020 events0 affected148 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events1 affected147 at risk EG0020 events0 affected148 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0012 events2 affected147 at risk EG0028 events8 affected148 at risk
Dizziness postural	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0016 events3 affected147 at risk EG0020 events0 affected148 at risk
Dysaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected148 at risk EG0014 events4 affected147 at risk EG0024 events4 affected148 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Somnolence	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Tremor	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Panic disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Nephrocalcinosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Renal cyst	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0024 events4 affected148 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0023 events2 affected148 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected119 at risk EG0011 events1 affected113 at risk EG0020 events0 affected104 at risk
Breast calcifications	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected34 at risk EG0020 events0 affected44 at risk
Vulvovaginal inflammation	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected34 at risk EG0020 events0 affected44 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Cystic lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events1 affected148 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0022 events2 affected148 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0012 events1 affected147 at risk EG0020 events0 affected148 at risk
Asteatosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events1 affected147 at risk EG0020 events0 affected148 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0024 events4 affected148 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected148 at risk EG0011 events1 affected147 at risk EG0023 events3 affected148 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0020 events0 affected148 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events2 affected147 at risk EG0021 events1 affected148 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Cataract operation	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0012 events1 affected147 at risk EG0020 events0 affected148 at risk
Skin lesion removal	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Transurethral bladder resection	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Ureteric calculus removal	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Urethral stent insertion	Surgical and medical procedures	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk
Arteriosclerosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected148 at risk EG0011 events1 affected147 at risk EG0020 events0 affected148 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected148 at risk EG0011 events1 affected147 at risk EG0021 events1 affected148 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected148 at risk EG0010 events0 affected147 at risk EG0021 events1 affected148 at risk

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

ID	Title	Description
BG000	5 mg Tirzepatide	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
BG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
BG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
BG003	Total	Total of all reporting groups

ID	Title	Description	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.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	148	2	148	109	148
EG001	10 mg Tirzepatide	10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	147	11	147	108	147
EG002	15 mg Tirzepatide	15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.	148	11	148	124	148