A Study of Two Doses of Dulaglutide (LY2189265) in Japane... | NCT04809220

ID	Type	Description	Link
H9X-JE-GBGQ	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Dulaglutide 1.5 milligram (mg)	Experimental	Participants received 1.5 mg of dulaglutide given weekly subcutaneously (SC) during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 oral antihyperglycemic medication (OAM). Participants on dipeptidyl peptidase-4 inhibitors (DPP-4i) discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.	Drug: Dulaglutide Drug: Oral antihyperglycemics
Dulaglutide 0.75 mg	Active Comparator	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.	Drug: Dulaglutide Drug: Oral antihyperglycemics

Name	Type	Description	Arm Group Labels	Other Names
Dulaglutide	Drug	Administered SC	Dulaglutide 0.75 mg Dulaglutide 1.5 milligram (mg)

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.	Baseline, Week 26

Measure	Description	Time Frame
Change From Baseline in HbA1c at Week 52	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.	Baseline, Week 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
Have the following HbA1c result at screening.
- Participants taking DPP-4i: ≥7.5% and ≤9.5%,
- Participants taking another OAM: ≥8.0% and ≤10.0%
Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day 1.

Exclusion Criteria:

Have type 1 diabetes (T1D)
Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
Have a known clinically significant gastric empty abnormality
Have acute or chronic hepatitis
Have had chronic or acute pancreatitis
Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
Have evidence of significant, active autoimmune abnormality
Have evidence of significant, uncontrolled endocrine abnormality
Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
Have any hematologic condition that may interfere with HbA1c measurement

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

Facility	Status	City	State	ZIP	Country	Contacts
Nakayama Clinic		Nagoya	Aichi-ken	456-0058	Japan
Tosaki Clinic for Diabetes and Endocrinology

ID	Title	Description
FG000	Dulaglutide 1.5 Milligram (mg)	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 15, 2020	Aug 8, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables.

All randomly assigned participants, excluding the GCP compliance investigative site, who were exposed to at least 1 dose of study intervention and had at least one post baseline value for this analysis.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide

Units	Counts
Participants	OG000383 OG001193

Title

Denominators

Categories

Title	Measurements
	OG000-1.53± 0.043 OG001-1.25± 0.060

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		<.001		LS Mean Difference	-0.29			2-Sided	95	-0.43	-0.14					Superiority

Secondary

Change From Baseline in HbA1c at Week 52

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 52

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Secondary

Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%

HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Secondary

Change From Baseline in Fasting Serum Glucose (FSG)

FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, Week 52

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Secondary

Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG)

SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 26

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Secondary

Change From Baseline in Body Weight

LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment*Time as variables.

Posted

Least Squares Mean

Standard Error

kilogram (kg)

Baseline, Week 52

ID	Title	Description
OG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
OG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Retinal haemorrhage	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Covid-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Lateral medullary syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected195 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Bundle branch block right	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0014 events3 affected195 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Presbyacusis	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected195 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Age-related macular degeneration	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Asthenopia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected195 at risk
Blepharitis	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cataract	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected391 at risk EG0012 events2 affected195 at risk
Central serous chorioretinopathy	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Conjunctival deposit	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Corneal disorder	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Diabetic retinopathy	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected391 at risk EG0012 events2 affected195 at risk
Dry eye	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected391 at risk EG0011 events1 affected195 at risk
Eczema eyelids	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Glaucoma	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Macular oedema	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Ocular hyperaemia	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Ocular hypertension	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Retinal haemorrhage	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Retinal tear	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Retinal vein occlusion	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00026 events24 affected391 at risk EG0015 events5 affected195 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected391 at risk EG0012 events2 affected195 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events2 affected195 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0012 events2 affected195 at risk
Anal fissure haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0016 events6 affected195 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00051 events49 affected391 at risk EG00117 events17 affected195 at risk
Dental caries	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0015 events5 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000138 events40 affected391 at risk EG00117 events16 affected195 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00017 events14 affected391 at risk EG0016 events6 affected195 at risk
Ectopic gastric mucosa	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Eructation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Faeces hard	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Flatulence	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected391 at risk EG0010 events0 affected195 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0011 events1 affected195 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected391 at risk EG0010 events0 affected195 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00010 events10 affected391 at risk EG0012 events2 affected195 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events1 affected195 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0012 events2 affected195 at risk
Melaena	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00066 events35 affected391 at risk EG0019 events9 affected195 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0010 events0 affected195 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0013 events3 affected195 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00023 events11 affected391 at risk EG0012 events2 affected195 at risk
Application site pruritus	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Chest discomfort	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0015 events3 affected195 at risk
Chills	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected195 at risk
Cyst	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Discomfort	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Face oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events2 affected195 at risk
Feeling abnormal	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Injection site bruising	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0016 events2 affected195 at risk
Injection site erythema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected195 at risk
Injection site induration	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Injection site pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected195 at risk
Injection site pruritus	General disorders	MedDRA 26.0	Systematic Assessment	EG00027 events5 affected391 at risk EG0012 events2 affected195 at risk
Injection site reaction	General disorders	MedDRA 26.0	Systematic Assessment	EG00052 events11 affected391 at risk EG00158 events5 affected195 at risk
Injection site swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG00014 events14 affected391 at risk EG0017 events5 affected195 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00048 events39 affected391 at risk EG00119 events14 affected195 at risk
Thirst	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Vaccination site pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Hyperplastic cholecystopathy	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Non-alcoholic fatty liver	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0013 events3 affected195 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Food allergy	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Seasonal allergy	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Acute sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Bacterial infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected391 at risk EG0011 events1 affected195 at risk
Body tinea	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected195 at risk
Candida infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0012 events2 affected195 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected195 at risk
Coronavirus infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00018 events18 affected391 at risk EG0018 events8 affected195 at risk
Covid-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00030 events30 affected391 at risk EG00116 events16 affected195 at risk
Cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected391 at risk EG0011 events1 affected195 at risk
Dacryocystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dermatophytosis of nail	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Empyema	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Enteritis infectious	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Enterocolitis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Exanthema subitum	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Folliculitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected391 at risk EG0016 events5 affected195 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gingivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Helicobacter infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hepatitis e	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected391 at risk EG0014 events4 affected195 at risk
Hordeolum	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Nasal herpes	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00032 events22 affected391 at risk EG00120 events17 affected195 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Otitis externa	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0011 events1 affected195 at risk
Otitis media	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Periodontitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0014 events4 affected195 at risk
Pharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0008 events5 affected391 at risk EG0011 events1 affected195 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Post-acute covid-19 syndrome	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Rhinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Skin bacterial infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Tinea pedis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Tonsillitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected391 at risk EG0010 events0 affected195 at risk
Tooth infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Vulvitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected113 at risk EG0010 events0 affected53 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected195 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events1 affected195 at risk
Chillblains	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0005 events3 affected391 at risk EG0015 events5 affected195 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gingival injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0008 events7 affected391 at risk EG0014 events2 affected195 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0013 events3 affected195 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected391 at risk EG0010 events0 affected195 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected195 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0012 events2 affected195 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected391 at risk EG0010 events0 affected195 at risk
Amylase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected391 at risk EG0010 events0 affected195 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Blood pressure increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Blood triglycerides increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Carcinoembryonic antigen increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Diagnostic aspiration	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Helicobacter test positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Lipase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00012 events12 affected391 at risk EG0011 events1 affected195 at risk
Occult blood positive	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pancreatic enzymes increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00016 events16 affected391 at risk EG0016 events6 affected195 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected195 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0012 events2 affected195 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected391 at risk EG0010 events0 affected195 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00010 events7 affected391 at risk EG0019 events8 affected195 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Zinc deficiency	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected391 at risk EG0018 events8 affected195 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00013 events12 affected391 at risk EG0014 events4 affected195 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0012 events2 affected195 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events3 affected195 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0005 events4 affected391 at risk EG0015 events4 affected195 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0012 events2 affected195 at risk
Nodal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0007 events6 affected391 at risk EG0011 events1 affected195 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0012 events2 affected195 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0012 events2 affected195 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Spinal ligament ossification	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0012 events2 affected195 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0012 events2 affected195 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0011 events1 affected195 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Gastrointestinal submucosal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected142 at risk
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected113 at risk EG0010 events0 affected53 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0010 events0 affected195 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected391 at risk EG0015 events5 affected195 at risk
Dizziness postural	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Head discomfort	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00012 events12 affected391 at risk EG00111 events8 affected195 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected391 at risk EG0010 events0 affected195 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Migraine	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Sciatica	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Taste disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Tension headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Depressive symptom	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Initial insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected391 at risk EG0010 events0 affected195 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0013 events2 affected195 at risk
Sleep disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Renal cyst	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0013 events3 affected195 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0011 events1 affected142 at risk
Endometrial disorder	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected53 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Pelvic cyst	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected278 at risk EG0010 events0 affected142 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0010 events0 affected195 at risk
Cough variant asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Vasomotor rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Androgenetic alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected391 at risk EG0011 events1 affected195 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0012 events2 affected195 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0016 events6 affected195 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0011 events1 affected195 at risk
Palmoplantar keratoderma	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0010 events0 affected195 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0012 events2 affected195 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0013 events1 affected195 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected391 at risk EG0011 events1 affected195 at risk
Breast conserving surgery	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Cataract operation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected391 at risk EG0010 events0 affected195 at risk
Cervical conisation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected53 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Internal fixation of fracture	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected391 at risk EG0013 events2 affected195 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Lipoma excision	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Medical device removal	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Meniscus removal	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Nephrectomy	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Polypectomy	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected391 at risk EG0010 events0 affected195 at risk
Rectal polypectomy	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Synovial cyst removal	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected391 at risk EG0013 events3 affected195 at risk
Tumour excision	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Arteriosclerosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00010 events10 affected391 at risk EG0011 events1 affected195 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk
Internal haemorrhage	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected391 at risk EG0010 events0 affected195 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected391 at risk EG0011 events1 affected195 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Title	Description
BG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
BG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dulaglutide 1.5 mg	Participants received 1.5 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.	1	391	15	391	298	391
EG001	Dulaglutide 0.75 mg	Participants received 0.75 mg of dulaglutide given weekly SC during the 52-week treatment period. Dulaglutide will be given alone or in combination with 1 OAM. Participants on DPP-4i discontinued DPP-4i at randomization and was regarded as monotherapy of dulaglutide, other OAMs continued at same dose during study period and were regarded as combination therapy with dulaglutide.	0	195	7	195	143	195