A Study of Tirzepatide (LY3298176) in Participants With N... | NCT04166773

ID	Type	Description	Link
I8F-MC-GPHR	Other Identifier	Eli Lilly and Company
2019-001550-26	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 mg Tirzepatide	Experimental	5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	Drug: Tirzepatide
10 mg Tirzepatide	Experimental	10 mg tirzepatide administered SC once a week.	Drug: Tirzepatide
15 mg Tirzepatide	Experimental	15 mg tirzepatide administered SC once a week.	Drug: Tirzepatide
Placebo	Placebo Comparator	Placebo administered SC once a week.	Drug: Placebo

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology	NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.	Week 52

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology	NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score).

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama-The Kirklin Clinic		Birmingham	Alabama	35205	United States
Synexus Clinical Research US, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38856224	Derived	Loomba R, Hartman ML, Lawitz EJ, Vuppalanchi R, Boursier J, Bugianesi E, Yoneda M, Behling C, Cummings OW, Tang Y, Brouwers B, Robins DA, Nikooie A, Bunck MC, Haupt A, Sanyal AJ; SYNERGY-NASH Investigators. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. N Engl J Med. 2024 Jul 25;391(4):299-310. doi: 10.1056/NEJMoa2401943. Epub 2024 Jun 8.

Label	URL
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	5 Milligram (mg) Tirzepatide	Participants received 5 mg tirzepatide administered subcutaneously (SC) once a week (QW) for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
FG001	10 mg Tirzepatide

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 19, 2020	Dec 6, 2024

Arm/Group Information

ID	Title	Description
BG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
BG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].
BG002	15 mg Tirzepatide	Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].
BG003	Placebo	Participants received placebo administered SC QW for 52 weeks.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.00± 11.62 BG00154.30± 12.08 BG00254.90± 10.02 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00126 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00019 BG00115 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Belgium

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology

NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].
OG002	15 mg Tirzepatide	Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].
OG003	Placebo	Participants received placebo administered SC QW for 52 weeks.

Units	Counts
Participants	OG00039 OG00141 OG00240 OG003

Title

Denominators

Categories

Title	Measurements
	OG00051.84 OG00163.13 OG00273.92 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Regression, Logistic		<0.001		Odds Ratio (OR)	7.45			2-Sided	95	2.27	24.44			Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.		Superiority
OG001 OG003

Secondary

Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology

NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score).

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks then 5 mg tirzepatide SC QW from week 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].

Secondary

Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology

Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis.

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].
OG002	15 mg Tirzepatide	Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].

Secondary

Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components

Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease.

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Number

Percentage of participants

Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].
OG002

Secondary

Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%) and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Diabetes Flag (DIABFL) + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Least Squares Mean

Standard Error

absolute percentage of liver fat

Baseline to Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].

Secondary

Mean Change From Baseline in Body Weight

Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.

All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.

Posted

Least Squares Mean

Standard Error

Kilogram (kg)

Baseline to Week 52

ID	Title	Description
OG000	5 mg Tirzepatide	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from week 5-52].
OG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg and 10 mg every 4 weeks until target dose (10 mg) was reached].
OG002	15 mg Tirzepatide	Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].

Arm/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	Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].	47	5	47	43	47
EG001	10 mg Tirzepatide	Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].	47	4	47	43	47
EG002	15 mg Tirzepatide	Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].	48	0	48	44	48
EG003	Placebo	Participants received placebo administered SC QW for 52 weeks.	48	3	48	40	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Developmental hip dysplasia	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG0030 events0 affected48 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Covid-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected29 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Endometrial thickening	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected29 at risk EG003
Phlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG0031 events1 affected48 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Palpitations	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Gilbert's syndrome	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Cataract	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Eye pain	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Meibomian gland dysfunction	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Vision blurred	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0016 events4 affected47 at risk EG0020 events0 affected48 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected47 at risk EG0013 events3 affected47 at risk EG0028 events6 affected48 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00012 events6 affected47 at risk EG0014 events3 affected47 at risk EG0027 events4 affected48 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00010 events6 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Bowel movement irregularity	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Colonic angioectasia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00012 events11 affected47 at risk EG00112 events9 affected47 at risk EG0028 events7 affected48 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00017 events15 affected47 at risk EG00140 events17 affected47 at risk EG00220 events13 affected48 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected47 at risk EG00111 events8 affected47 at risk EG0022 events2 affected48 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events2 affected47 at risk EG0025 events4 affected48 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0013 events3 affected47 at risk EG0024 events3 affected48 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events1 affected48 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0015 events3 affected47 at risk EG0025 events4 affected48 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00069 events17 affected47 at risk EG00133 events16 affected47 at risk EG00226 events21 affected48 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected47 at risk EG0021 events1 affected48 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Tooth loss	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected47 at risk EG0015 events3 affected47 at risk EG00214 events7 affected48 at risk EG003
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected47 at risk EG0016 events4 affected47 at risk EG0020 events0 affected48 at risk EG003
Chest discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0024 events1 affected48 at risk EG003
Energy increased	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected47 at risk EG0015 events4 affected47 at risk EG0025 events5 affected48 at risk EG003
Injection site bruising	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Injection site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0022 events1 affected48 at risk EG003
Injection site inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Injection site rash	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Injection site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0005 events2 affected47 at risk EG0012 events1 affected47 at risk EG00210 events2 affected48 at risk EG003
Injection site swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Thirst	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Vaccination site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Hepatic fibrosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hepatic haematoma	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected29 at risk EG003
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected47 at risk EG0016 events6 affected47 at risk EG0029 events9 affected48 at risk EG003
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Folliculitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Fungal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events2 affected48 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Infected bite	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0022 events2 affected48 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Otitis media	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Paronychia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0012 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Tooth infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0013 events3 affected47 at risk EG0021 events1 affected48 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0014 events3 affected47 at risk EG0022 events2 affected48 at risk EG003
Viral rhinitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected29 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected29 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Post vaccination syndrome	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events1 affected48 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Amylase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Bacterial test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Biopsy liver	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Blood glucose decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Haematocrit abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Haemoglobin abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected47 at risk EG0011 events1 affected47 at risk EG0024 events3 affected48 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Sars-cov-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Urine albumin/creatinine ratio increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected47 at risk EG0013 events3 affected47 at risk EG0024 events4 affected48 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected47 at risk EG00112 events10 affected47 at risk EG00212 events11 affected48 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected47 at risk EG0012 events2 affected47 at risk EG0022 events2 affected48 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected47 at risk EG0011 events1 affected47 at risk EG0021 events1 affected48 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Greater trochanteric pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Immune-mediated myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0012 events2 affected47 at risk EG0021 events1 affected48 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Hepatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected29 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Aphasia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0017 events6 affected47 at risk EG0024 events4 affected48 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events2 affected47 at risk EG0020 events0 affected48 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected47 at risk EG0017 events6 affected47 at risk EG0024 events3 affected48 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Lethargy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events1 affected48 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00017 events1 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Neuritis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Sciatica	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Somnolence	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Taste disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected47 at risk EG0021 events1 affected48 at risk EG003
Tension headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Tremor	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Major depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Microalbuminuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected19 at risk EG003
Breast cyst	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Breast discomfort	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events1 affected48 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected29 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected19 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected29 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected29 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0022 events2 affected48 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0011 events1 affected47 at risk EG0023 events3 affected48 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected47 at risk EG0012 events2 affected47 at risk EG0025 events3 affected48 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0012 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Koilonychia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Cyst removal	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Eyelid cyst removal	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Gastrointestinal endoscopic therapy	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Knee arthroplasty	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Large intestinal polypectomy	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0012 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Nail operation	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Skin neoplasm excision	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Tendon sheath incision	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Uterine polypectomy	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected29 at risk EG003
Hot flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0013 events3 affected47 at risk EG0020 events0 affected48 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected47 at risk EG0010 events0 affected47 at risk EG0020 events0 affected48 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0010 events0 affected47 at risk EG0021 events1 affected48 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected47 at risk EG0011 events1 affected47 at risk EG0020 events0 affected48 at risk EG003

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive 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