A Study to Determine the Safety and Efficacy of Albigluti... | NCT00839527

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin + glimepiride + pioglitazone + albiglutide placebo	Active Comparator	Metformin + glimepiride + pioglitazone + matching albiglutide placebo	Drug: placebo to match albiglutide Drug: metformin Drug: glimepiride Drug: pioglitazone
metformin + glimepiride + pioglitazone placebo + albiglutide	Experimental	Metformin + open-label glimepiride + pioglitazone matching placebo + albiglutide	Biological: albiglutide Drug: metformin Drug: glimepiride Drug: placebo to match pioglitazone
met + glimepiride + pioglitazone placebo + albiglutide placebo	Active Comparator	metformin + open-label glimepiride + pioglitazone placebo + albiglutide placebo	Drug: placebo to match albiglutide Drug: metformin Drug: glimepiride Drug: placebo to match pioglitazone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo to match albiglutide	Drug	albiglutide matching placebo weekly subcutaneous injection	met + glimepiride + pioglitazone placebo + albiglutide placebo metformin + glimepiride + pioglitazone + albiglutide placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.	Baseline and Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c at Week 104 and Week 156	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Alabaster	Alabama	35007	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28683300	Derived	Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.
25387217

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
112757	Clinical Study Report	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
BG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
BG002	Albiglutide + Metformin + Glimepiride	Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
BG003	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
	BG00055.7± 9.59 BG00155.7± 9.39 BG00254.5± 9.47 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00045 BG001129 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

African American/African Heritage

Title	Measurements
	BG00010 BG00124 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

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.

Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c in the blood

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG002	Albiglutide + Metformin + Glimepiride	Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Units	Counts
Participants	OG000115 OG001268 OG002265

Title

Denominators

Categories

Title	Measurements
	OG0000.33± 0.083 OG001-0.80± 0.055 OG002-0.55± 0.055

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		ANCOVA		<0.0001		Mean Difference (Net)	-0.87			2-Sided	95	-1.07	-0.68				No	Superiority or Other
OG001 OG002		t-test, 1 sided		0.2685

Secondary

Change From Baseline in HbA1c at Week 104 and Week 156

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).

Posted

Mean

Standard Deviation

Percentage of HbA1c in the blood

Baseline, Week 104, and Week 156

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.

Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

Posted

Least Squares Mean

Standard Error

Millimoles per liter (mmol/L)

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in FPG at Week 104 and Week 156

The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

Baseline, Week 104, and Week 156

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and \

ITT Population

Posted

Median

95% Confidence Interval

Weeks

From the start of study medication until the end of the treatment (up to Week 156)

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride

Secondary

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.

Posted

Number

Participants

Week 52

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

Posted

Number

Participants

Week 156

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Body Weight at Week 52

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.

ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.

Posted

Least Squares Mean

Standard Error

Kilograms

Baseline and Week 52

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Secondary

Change From Baseline in Body Weight at Week 104 and Week 156

The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.

ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).

Posted

Mean

Standard Deviation

Kilograms

Baseline, Week 104, and Week 156

ID	Title	Description
OG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
OG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo + Metformin + Glimepiride	Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.	21	115	81	115
EG001	Pioglitazone + Metformin + Glimepiride	Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.	48	277	228	277
EG002	Albiglutide + Metformin + Glimepiride	Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.	39	271	228	271

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0014 affected277 at risk EG0023 affected271 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0014 affected277 at risk EG0020 affected271 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0023 affected271 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0012 affected277 at risk EG0020 affected271 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0022 affected271 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0021 affected271 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Arteriosclerosis coronary	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0011 affected277 at risk EG0022 affected271 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Diabetic foot infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Febrile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Infected bites	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Pancreatitis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0013 affected277 at risk EG0020 affected271 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0012 affected277 at risk EG0020 affected271 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0012 affected277 at risk EG0020 affected271 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Myelitis transverse	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Nerve compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Vith nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0022 affected271 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0022 affected271 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0021 affected271 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Sigmoiditis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0022 affected271 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0014 affected277 at risk EG0022 affected271 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0012 affected277 at risk EG0020 affected271 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Panic disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Glomerulonephritis acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0010 affected277 at risk EG0020 affected271 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0022 affected271 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0020 affected271 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0010 affected277 at risk EG0021 affected271 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0011 affected277 at risk EG0021 affected271 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00016 affected115 at risk EG00128 affected277 at risk EG00243 affected271 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00021 affected115 at risk EG00150 affected277 at risk EG00234 affected271 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected115 at risk EG00131 affected277 at risk EG00224 affected271 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected115 at risk EG00116 affected277 at risk EG00218 affected271 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected115 at risk EG00125 affected277 at risk EG00216 affected271 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG00110 affected277 at risk EG00216 affected271 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG00110 affected277 at risk EG0029 affected271 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG0019 affected277 at risk EG0028 affected271 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0013 affected277 at risk EG0026 affected271 at risk
Furuncle	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0012 affected277 at risk EG0026 affected271 at risk
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG0013 affected277 at risk EG0025 affected271 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0011 affected277 at risk EG0024 affected271 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG00113 affected277 at risk EG0022 affected271 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00028 affected115 at risk EG001115 affected277 at risk EG00284 affected271 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0014 affected277 at risk EG0027 affected271 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0013 affected277 at risk EG0025 affected271 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0024 affected271 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected115 at risk EG00123 affected277 at risk EG00237 affected271 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected115 at risk EG00120 affected277 at risk EG00230 affected271 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0017 affected277 at risk EG00217 affected271 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected115 at risk EG00111 affected277 at risk EG00214 affected271 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0019 affected277 at risk EG00212 affected271 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0012 affected277 at risk EG00210 affected271 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG00114 affected277 at risk EG0026 affected271 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0017 affected277 at risk EG0026 affected271 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0015 affected277 at risk EG0025 affected271 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0019 affected277 at risk EG0024 affected271 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0023 affected271 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected115 at risk EG00123 affected277 at risk EG00226 affected271 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0008 affected115 at risk EG00124 affected277 at risk EG00224 affected271 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG00114 affected277 at risk EG00212 affected271 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0017 affected277 at risk EG00212 affected271 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected115 at risk EG00112 affected277 at risk EG00211 affected271 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG00111 affected277 at risk EG0028 affected271 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0025 affected271 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG0018 affected277 at risk EG0024 affected271 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0022 affected271 at risk
Injection site reaction	General disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0018 affected277 at risk EG00232 affected271 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0009 affected115 at risk EG00141 affected277 at risk EG00212 affected271 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0006 affected115 at risk EG00115 affected277 at risk EG0028 affected271 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0022 affected271 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0018 affected277 at risk EG0021 affected271 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected115 at risk EG00125 affected277 at risk EG00221 affected271 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected115 at risk EG0019 affected277 at risk EG00216 affected271 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG00112 affected277 at risk EG00213 affected271 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0017 affected277 at risk EG0027 affected271 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG0014 affected277 at risk EG0024 affected271 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected115 at risk EG00119 affected277 at risk EG00228 affected271 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0012 affected277 at risk EG0027 affected271 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0019 affected277 at risk EG0025 affected271 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0016 affected277 at risk EG0022 affected271 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0014 affected277 at risk EG0028 affected271 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG0018 affected277 at risk EG0027 affected271 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected115 at risk EG0016 affected277 at risk EG0027 affected271 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 affected115 at risk EG0017 affected277 at risk EG0024 affected271 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0018 affected277 at risk EG0023 affected271 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0011 affected277 at risk EG0022 affected271 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00011 affected115 at risk EG00127 affected277 at risk EG00222 affected271 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG00117 affected277 at risk EG00210 affected271 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG00113 affected277 at risk EG0028 affected271 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected115 at risk EG0019 affected277 at risk EG00211 affected271 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0017 affected277 at risk EG0029 affected271 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG00112 affected277 at risk EG0025 affected271 at risk
Cardiac murmur	Investigations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG0013 affected277 at risk EG0026 affected271 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0011 affected277 at risk EG0026 affected271 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0016 affected277 at risk EG0021 affected271 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected115 at risk EG00121 affected277 at risk EG0020 affected271 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG00124 affected277 at risk EG00213 affected271 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0010 affected277 at risk EG0022 affected271 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG0019 affected277 at risk EG0025 affected271 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0016 affected277 at risk EG0022 affected271 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0012 affected277 at risk EG0022 affected271 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected115 at risk EG0017 affected277 at risk EG0029 affected271 at risk
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0003 affected115 at risk EG0014 affected277 at risk EG0025 affected271 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0004 affected115 at risk EG0013 affected277 at risk EG0022 affected271 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
C534611	rGLP-1 protein
D008687	Metformin
C057619	glimepiride
D000077205	Pioglitazone