Efficacy and Safety of Semaglutide Once-weekly Versus Exe... | NCT01885208

NCT01885208

ID	Type	Description	Link
2012-004826-92	EudraCT Number
U1111-1135-8647	Other Identifier	WHO

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Semaglutide 1.0 mg	Experimental		Drug: semaglutide
Exenatide ER 2.0 mg	Active Comparator		Drug: exenatide

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly	Semaglutide 1.0 mg

Outcomes Module

Measure	Description	Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Mean change in HbA1c from baseline to week 56.	Week 0, week 56

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Body Weight	Mean change in body weight from baseline to week 56.	Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)	Mean change in FPG from baseline to week 56.

Eligibility Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Anniston	Alabama	36207	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30938762	Background	Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.
30865526	Background

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
BG001	Exenatide ER 2.0 mg	Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.
BG002	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
	OG000-1.54± 0.06 OG001-0.92± 0.06

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	The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.	Mixed Models Analysis		< 0.0001		Treatment difference	-0.62			2-Sided	95	-0.8	-0.44					Non-Inferiority	Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).

Secondary

Change From Baseline in Body Weight

Mean change in body weight from baseline to week 56.

The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

Posted

Least Squares Mean

Standard Error

kilograms

Week 0, week 56

ID	Title	Description
OG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
OG001	Exenatide ER 2.0 mg	Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG)

Mean change in FPG from baseline to week 56.

The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

Posted

Least Squares Mean

Standard Error

mg/dL

Week 0, week 56

ID	Title	Description
OG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
OG001	Exenatide ER 2.0 mg	Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.

Secondary

Change From Baseline in Systolic and Diastolic Blood Pressure

Mean changes in systolic and diastolic blood pressure from baseline to week 56.

The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

Posted

Least Squares Mean

Standard Error

mm Hg

Week 0, week 56

ID	Title	Description
OG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
OG001	Exenatide ER 2.0 mg	Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.

Secondary

Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)

The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.

The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0, week 56

ID	Title	Description
OG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.

Secondary

Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)

The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.

The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

Posted

Count of Participants

Participants

After 56 weeks' treatment

ID	Title	Description
OG000	Semaglutide 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD) therapy throughout the trial, unless rescue medication was needed.
OG001	Exenatide ER 2.0 mg	Subjects randomised to exenatide extended release (ER) 2.0 mg (Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sema 1.0 mg	Subjects randomised to semaglutide followed a fixed dose-escalation regimen for a period of 56 weeks. Subjects started with once-weekly doses of 0.25 mg for 4 weeks, then escalated to doses of 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and was to be administered subcutaneously (s.c.; under the skin) either in the thigh, abdomen or upper arm at the same weekday. All subjects continued their pre-trial treatment of 1-2 oral anti-diabetes drug (OAD)therapy throughout the trial, unless rescue medication was needed.			38	404	194	404
EG001	Exenatide ER	Subjects randomised to exenatide extended release (ER) 2.0 mg(Bydureon®) were treated with the same 2.0 mg dose for a period of 56 weeks. Exenatide one vial of 2 mg exenatide ER was supplied in a pre-filled syringe of 0.65 mL solvent and to be administrated subcutaneously (s.c.; under the skin) once weekly through out the trial. All subjects continued their pre-trial treatment of 1-2 OAD therapy entire trial, unless rescue medication was needed.			24	405	187	405

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Abortion induced	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Angina pectoris	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Anxiety	Psychiatric disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Aphasia	Nervous system disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0013 events3 affected405 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0011 events1 affected405 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Castleman's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Cellulitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0011 events1 affected405 at risk
Chest discomfort	General disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Chest pain	General disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0002 events2 affected404 at risk EG0010 events0 affected405 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Dizziness	Nervous system disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0011 events1 affected405 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Encephalitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Gastroenteritis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0012 events2 affected405 at risk
Glycosuria	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
HIV test positive	Investigations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Liver function test abnormal	Investigations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Meniscus removal	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0002 events2 affected404 at risk EG0010 events0 affected405 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0003 events3 affected404 at risk EG0010 events0 affected405 at risk
Pneumonia	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0011 events1 affected405 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Renal colic	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Sepsis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Surgical failure	General disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Urinary tract infection	Infections and infestations	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Urosepsis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG0011 events1 affected405 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected404 at risk EG0010 events0 affected405 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00028 events26 affected404 at risk EG00126 events21 affected405 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18	Systematic Assessment	EG00034 events32 affected404 at risk EG00124 events21 affected405 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00086 events46 affected404 at risk EG00158 events34 affected405 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00033 events27 affected404 at risk EG00123 events19 affected405 at risk
Headache	Nervous system disorders	MedDRA 18	Systematic Assessment	EG00081 events38 affected404 at risk EG00165 events39 affected405 at risk
Injection site nodule	General disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected404 at risk EG00155 events49 affected405 at risk
Lipase increased	Investigations	MedDRA 18	Systematic Assessment	EG00051 events41 affected404 at risk EG00164 events49 affected405 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG00046 events39 affected404 at risk EG00151 events38 affected405 at risk
Nausea	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG000159 events90 affected404 at risk EG00170 events48 affected405 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00037 events29 affected404 at risk EG00140 events25 affected405 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

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

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors