The Efficacy of Insulin Degludec/Liraglutide as add-on Th... | NCT01618162

NCT01618162

ID	Type	Description	Link
2012-000140-97	EudraCT Number
U1111-1126-9776	Other Identifier	WHO

Status Module

Oversight Module

Description Module

Label	Type	Description	Intervention Names
Insulin degludec/liraglutide	Experimental		Drug: insulin degludec/liraglutide
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/liraglutide	Drug	Injected subcutaneously (under the skin) once daily. Dose individually adjusted.	Insulin degludec/liraglutide

Outcomes Module

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Change in HbA1c from baseline to 26 weeks.	Week 0, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)	Percentage of subjects having HbA1c below 7% at week 26.	Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with type 2 diabetes mellitus
HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
Screening calcitonin above or equal to 50 ng/l
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product
History of chronic pancreatitis or idiopathic acute pancreatitis

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		Anaheim	California	92801	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28332144	Background	Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
27589252

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDegLira	In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
BG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
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
	BG00060± 9.6 BG00159.4± 10.8 BG00259.8± 10.0

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000135 BG00173 BG002

Glycosylated haemoglobin

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.9± 0.6 BG0017.9± 0.6 BG002

Fasting plasma glucose

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.1± 2.2 BG0019.1± 2.1 BG002

Body weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00087.2± 18.6 BG00189.3± 17.5 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 in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c from baseline to 26 weeks.

Full analysis set.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Units	Counts
Participants	OG000289 OG001146

Title

Denominators

Categories

Title	Measurements
	OG000-1.45± 0.84 OG001-0.46± 0.83

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	Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.	ANCOVA		< 0.001		Estimated treatment difference	-1.02			2-Sided	95	-1.18	-0.87					Superiority or Other

Secondary

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Percentage of subjects having HbA1c below 7% at week 26.

Full analysis set.

Posted

Number

percentage of subjects

Week 26

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Secondary

Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Percentage of subjects having HbA1c below 6.5% at week 26

Full analysis set.

Posted

Number

percentage of subjects

Week 26

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline in FPG at week 26.

Full analysis set. Number of subjects analyzed=subjects with data available for FPG.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 26

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Secondary

Change From Baseline in Body Weight

Change from baseline in body weight at week 26.

Full analysis set.

Posted

Mean

Standard Deviation

kilogram

Week 0, week 26

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Secondary

Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes

An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.

Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.

Minor hypoglycaemic episodes were defined as:

An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).

Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).

Safety analysis set included all subjects receiving at least one dose of the trial product.

Posted

Number

event rate per 100 PYE

After 26 weeks of treatment

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

Secondary

Number of Adverse Events (AEs)

An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.

Safety analysis set.

Posted

Number

event rate per 100 PYE

After 26 weeks of treatment

ID	Title	Description
OG000	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
OG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).

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	IDegLira	In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).			14	288	83	288
EG001	Placebo	In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).			5	146	38	146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Amylase increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected146 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected146 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Dengue fever	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected146 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected146 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected146 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Lipase increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Meningitis haemophilus	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Normal tension glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected146 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected146 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Thalamic infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00019 events19 affected288 at risk EG0017 events6 affected146 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00018 events15 affected288 at risk EG00111 events8 affected146 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected288 at risk EG0019 events8 affected146 at risk
Lipase increased	Investigations	MedDRA	Systematic Assessment	EG00029 events27 affected288 at risk EG0018 events6 affected146 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00029 events25 affected288 at risk EG00115 events12 affected146 at risk

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