Safety and Efficacy Study of Albiglutide Liquid Drug Prod... | NCT02683746

Label	Type	Description	Intervention Names
Albiglutide active LAI plus Placebo lyophilized DCC PI	Experimental	Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	Drug: Lyophilized albiglutide DCC pen injector matching placebo Drug: Albiglutide liquid auto-injector
Albiglutide lyophilized DCC PI plus Placebo LAI	Experimental	Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	Drug: Lyophilized albiglutide DCC pen injector Drug: Albiglutide liquid auto-injector matching placebo

Name	Type	Description	Arm Group Labels	Other Names
Lyophilized albiglutide DCC pen injector	Drug	A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL.

Measure	Description	Time Frame
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26	Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.	Baseline and Week 26

Measure	Description	Time Frame
Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35216	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
31004676	Background	Shaddinger BC, Soffer J, Vlasakakis G, Shabbout M, Weston C, Nino A. Efficacy and safety of an albiglutide liquid formulation compared with the lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019 Jun;152:125-134. doi: 10.1016/j.diabres.2019.04.018. Epub 2019 Apr 18.

ID	Title	Description
FG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 26, 2016	Jan 30, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.

Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment and have a Baseline assessment.

Posted

Least Squares Mean

Standard Error

Percentage of total hemoglobin

Baseline and Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Units	Counts
Participants	OG000153 OG001154

Title

Denominators

Categories

Title	Measurements
	OG000-1.12± 0.072 OG001-1.18± 0.072

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM model		0.0002	P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.	Mean Difference (Net)	0.06			2-Sided	95	-0.13	0.24					Non-Inferiority	The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.

Secondary

Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.

Safety Population comprised of all enrolled participants who received at least one dose of study treatment.

Posted

Number

Participnats

Up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)

Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.

Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Hematology Parameters of PCC

Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.

Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Vital Signs of PCC

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.

Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Posted

Number

Participants

Up to Week 34

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Electrocardiogram (ECG) Parameters of PCC

Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.

Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Posted

Number

Participants

Up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Positive Result for Anti-albiglutide Antibody

Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.

Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Posted

Number

Participants

Up to Week 34

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Number of Participants With Injection Site Reactions (ISR)

Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.

Safety Population.

Posted

Number

Participants

Up to Week 34

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Units	Counts

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.

ITT Population. Only those participants available at Week 26 were analyzed.

Posted

Least Squares Mean

Standard Error

Mmol/L

Baseline and Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Change From Baseline in HbA1c Over Time

Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

ITT Population

Posted

Least Squares Mean

Standard Error

Percent of total hemoglobin

Baseline and up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Change From Baseline in FPG Over Time

ITT Population

Posted

Least Squares Mean

Standard Error

Mmol/L

Baseline and up to Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Secondary

Trough Plasma Concentration of Albiglutide Over Time

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

PK Population

Posted

Mean

Standard Deviation

Nanograms per milliliter (ng/mL)

Pre-dose at Week 12 and Week 26

ID	Title	Description
OG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
OG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0008 affected153 at risk EG00120 affected154 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00010 affected153 at risk EG00110 affected154 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0015 affected154 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0015 affected154 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0012 affected154 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0014 affected154 at risk
Viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected153 at risk EG0010 affected154 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Otitis externa	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Tooth abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Tooth infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Localised infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Abscess limb	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Acarodermatitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Acute sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Gingivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Groin abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Herpes simplex	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Incision site abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Laryngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Oral herpes	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Otitis media	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Otitis media chronic	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Papilloma viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Post procedural infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Vaginal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Viraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00017 affected153 at risk EG00125 affected154 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00015 affected153 at risk EG00111 affected154 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00013 affected153 at risk EG0012 affected154 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected153 at risk EG0016 affected154 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected153 at risk EG0016 affected154 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0016 affected154 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected153 at risk EG0013 affected154 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0013 affected154 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0013 affected154 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0012 affected154 at risk
Flatulence	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Dental caries	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Eructation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected153 at risk EG0013 affected154 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected153 at risk EG0015 affected154 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0013 affected154 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0013 affected154 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0011 affected154 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0010 affected154 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tendon sheath disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Injection site reaction	General disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected153 at risk EG0016 affected154 at risk
Injection site bruising	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0015 affected154 at risk
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0017 affected154 at risk
Injection site pruritus	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0015 affected154 at risk
Injection site rash	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0013 affected154 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0013 affected154 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Inflammation	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Injection site discolouration	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Injection site haematoma	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Injection site haemorrhage	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Injection site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Injection site irritation	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Injection site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Peripheral swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Vaccination site bruising	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Vessel puncture site haematoma	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Vessel puncture site reaction	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00012 affected153 at risk EG00114 affected154 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected153 at risk EG0016 affected154 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0010 affected154 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Nerve compression	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Periodic limb movement disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tension headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected153 at risk EG0015 affected154 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected153 at risk EG0015 affected154 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0014 affected154 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Allergic bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Vasomotor rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0013 affected154 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0015 affected154 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0014 affected154 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0013 affected154 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0010 affected154 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0012 affected154 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected153 at risk EG0016 affected154 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Hyperphagia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0012 affected154 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0011 affected154 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected153 at risk EG0017 affected154 at risk
Hot flush	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0013 affected154 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Binge eating	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Libido decreased	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Seasonal allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected153 at risk EG0015 affected154 at risk
Food allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Mitral valve calcification	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0012 affected154 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Cataract	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0011 affected154 at risk
Age-related macular degeneration	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Blepharitis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Erythema of eyelid	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Oligomenorrhoea	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Heart sounds abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Liver function test increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Albiglutide Liquid	Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
BG001	Albiglutide Lyophilized	Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Albiglutide Active LAI Plus Placebo Lyophilized DCC PI	Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	0	153	7	153	101	153
EG001	Albiglutide Lyophilized DCC PI Plus Placebo LAI	Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	0	154	9	154	94	154

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected153 at risk EG0010 affected154 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected153 at risk EG0011 affected154 at risk