Efficacy and Safety of Albiglutide in Treatment of Type 2... | NCT00838903

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
albiglutide + metformin	Experimental	Albiglutide + metformin + placebo sitagliptin + placebo glimepiride	Biological: albiglutide Drug: metformin Drug: placebo sitagliptin Drug: placebo glimepiride
sitagliptin + metformin	Active Comparator	Sitagliptin + metformin + placebo albiglutide + placebo glimepiride	Drug: sitagliptin Drug: metformin Biological: placebo albiglutide Drug: placebo glimepiride
glimepiride + metformin	Active Comparator	Glimepiride + metformin + placebo albiglutide + placebo sitagliptin	Drug: glimepiride Drug: metformin Biological: placebo albiglutide Drug: placebo sitagliptin
metformin + placebo	Active Comparator	Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride	Drug: metformin Biological: placebo albiglutide Drug: placebo sitagliptin Drug: placebo glimepiride

Name	Type	Description	Arm Group Labels	Other Names
albiglutide	Biological	albiglutide	albiglutide + metformin
sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104	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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.	Baseline and Week 104

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c at 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. 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		Birmingham	Alabama	35235	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.

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
112753	Clinical Study Report	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
BG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
BG002	Glimepiride 2 mg Plus Metformin	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
BG003	Albiglutide 30 mg Plus Metformin	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
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
	BG00056.1± 10.01 BG00154.3± 9.81 BG00254.4± 9.97 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00051 BG001163 BG002

Race/Ethnicity, Customized

A participant may have been counted in more than one category.

Number

Participants

Title

Denominators

Categories

African American/African Heritage

Title	Measurements
	BG00023 BG00135 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 104

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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.

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 104.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c in the blood

Baseline and Week 104

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG002	Glimepiride 2 mg Plus Metformin	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG003	Albiglutide 30 mg Plus Metformin	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Units	Counts
Participants	OG00097 OG001297 OG002299 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.27± 0.113 OG001-0.28± 0.065 OG002-0.36± 0.064 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		ANCOVA				Mean Difference (Net)	-0.91			2-Sided	95	-1.16	-0.65				No	Superiority or Other
OG001 OG003		ANCOVA

Secondary

Change From Baseline in HbA1c at 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. 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 .

Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.

Posted

Mean

Standard Deviation

Percentage of HbA1c in the blood

Baseline and Week 156

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104

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 104.

Posted

Least Squares Mean

Standard Error

Millimoles per liter (mmol/L)

Baseline and Week 104

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Secondary

Change From Baseline in FPG at 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.

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

Baseline and Week 156

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Secondary

Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104

The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.

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 104.

Posted

Number

Participants

Week 104

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG002

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 achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.

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

Posted

Number

Participants

Week 156

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG002	Glimepiride 2 mg Plus Metformin

Secondary

Time to Hyperglycemia Rescue

Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic 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. Only those participants with a value at Baseline and at the specified visit were analyzed.

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 Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001

Secondary

Change From Baseline in Body Weight at Week 104

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 prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.

Posted

Least Squares Mean

Standard Error

Kilograms

Baseline and Week 104

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

Secondary

Change From Baseline in Body Weight at 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 who were available at the indicated time points were analyzed.

Posted

Mean

Standard Deviation

Kilograms

Baseline and Week 156

ID	Title	Description
OG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Plus Metformin	Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	15	101	75	101
EG001	Sitagliptin 100 mg Plus Metformin	Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	32	302	229	302
EG002	Glimepiride 2 mg Plus Metformin	Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	36	307	258	307
EG003	Albiglutide 30 mg Plus Metformin	Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.	44	302	242	302

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0021 affected307 at risk EG0032 affected302 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0022 affected307 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0021 affected307 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected302 at risk EG0022 affected307 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Arteriospasm coronary	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0012 affected302 at risk EG0020 affected307 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Breast cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Oesophageal spasm	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0022 affected307 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Death	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Complicated migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Viith nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Dacryostenosis acquired	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected302 at risk EG0020 affected307 at risk EG003
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Cervical Polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected302 at risk EG0020 affected307 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected101 at risk EG00133 affected302 at risk EG00232 affected307 at risk EG00358 affected302 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected101 at risk EG00137 affected302 at risk EG00235 affected307 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG00131 affected302 at risk EG00230 affected307 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected101 at risk EG00126 affected302 at risk EG00223 affected307 at risk EG003
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected101 at risk EG00117 affected302 at risk EG00225 affected307 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG00116 affected302 at risk EG0029 affected307 at risk EG003
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected101 at risk EG00122 affected302 at risk EG00217 affected307 at risk EG003
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG00122 affected302 at risk EG00222 affected307 at risk EG003
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0025 affected307 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG0026 affected307 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0027 affected307 at risk EG003
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00110 affected302 at risk EG0027 affected307 at risk EG003
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG0022 affected307 at risk EG003
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0015 affected302 at risk EG0026 affected307 at risk EG003
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG0024 affected307 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0016 affected302 at risk EG0021 affected307 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG0025 affected307 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected101 at risk EG00128 affected302 at risk EG00231 affected307 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00013 affected101 at risk EG00122 affected302 at risk EG00225 affected307 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG00114 affected302 at risk EG00213 affected307 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 affected101 at risk EG0018 affected302 at risk EG00213 affected307 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0015 affected302 at risk EG0028 affected307 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG00112 affected302 at risk EG0028 affected307 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0017 affected302 at risk EG0027 affected307 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG00110 affected302 at risk EG00210 affected307 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0016 affected302 at risk EG0023 affected307 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0017 affected302 at risk EG0028 affected307 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0017 affected302 at risk EG0022 affected307 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG00131 affected302 at risk EG00228 affected307 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG00111 affected302 at risk EG0026 affected307 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG00122 affected302 at risk EG00219 affected307 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00115 affected302 at risk EG00221 affected307 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00111 affected302 at risk EG0029 affected307 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0018 affected302 at risk EG0029 affected307 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0015 affected302 at risk EG0023 affected307 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0017 affected302 at risk EG0025 affected307 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0010 affected302 at risk EG0027 affected307 at risk EG003
Hypoglycaemia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00018 affected101 at risk EG00124 affected302 at risk EG002102 affected307 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG00111 affected302 at risk EG0025 affected307 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0018 affected302 at risk EG00212 affected307 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0014 affected302 at risk EG0026 affected307 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0013 affected302 at risk EG0023 affected307 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0014 affected302 at risk EG0027 affected307 at risk EG003
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG00126 affected302 at risk EG00234 affected307 at risk EG003
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG00113 affected302 at risk EG00214 affected307 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0015 affected302 at risk EG0027 affected307 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0015 affected302 at risk EG0027 affected307 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0013 affected302 at risk EG0025 affected307 at risk EG003
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0011 affected302 at risk EG0021 affected307 at risk EG003
Amnesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0010 affected302 at risk EG0021 affected307 at risk EG003
Injection site reaction	General disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0015 affected302 at risk EG0029 affected307 at risk EG003
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG00110 affected302 at risk EG00225 affected307 at risk EG003
Injection site haematoma	General disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG00111 affected302 at risk EG00211 affected307 at risk EG003
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0018 affected302 at risk EG0026 affected307 at risk EG003
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0016 affected302 at risk EG0025 affected307 at risk EG003
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0023 affected307 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG00124 affected302 at risk EG00228 affected307 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG00216 affected307 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0014 affected302 at risk EG00210 affected307 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0015 affected302 at risk EG0029 affected307 at risk EG003
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00128 affected302 at risk EG00232 affected307 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0017 affected302 at risk EG00214 affected307 at risk EG003
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00112 affected302 at risk EG00220 affected307 at risk EG003
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0014 affected302 at risk EG0027 affected307 at risk EG003
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0019 affected302 at risk EG00210 affected307 at risk EG003
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0016 affected302 at risk EG00210 affected307 at risk EG003
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0016 affected302 at risk EG0029 affected307 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0013 affected302 at risk EG0027 affected307 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0012 affected302 at risk EG0025 affected307 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0014 affected302 at risk EG0029 affected307 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected302 at risk EG0020 affected307 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0018 affected302 at risk EG0029 affected307 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG00114 affected302 at risk EG00212 affected307 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0018 affected302 at risk EG0025 affected307 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0010 affected302 at risk EG0022 affected307 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0013 affected302 at risk EG0025 affected307 at risk EG003
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0014 affected302 at risk EG0024 affected307 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0013 affected302 at risk EG0021 affected307 at risk EG003
Weight Increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected302 at risk EG0027 affected307 at risk EG003

Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.

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
C534611	rGLP-1 protein
D000068900	Sitagliptin Phosphate
C057619	glimepiride
D008687	Metformin

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals