Comparison of NN5401 Plus Insulin Aspart With Insulin Det... | NCT00978627

ID	Type	Description
2008-005769-71	EudraCT Number
U1111-1111-8943	Other Identifier	WHO
2009-013412-13	EudraCT Number
U1111-1113-2475	Other Identifier	WHO

Label	Type	Description	Intervention Names
IDegAsp OD	Experimental		Drug: insulin degludec/insulin aspart Drug: insulin aspart
IDet	Active Comparator		Drug: insulin detemir Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/insulin aspart	Drug	Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.	IDegAsp OD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.	Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Secondary Outcomes

Measure	Description	Time Frame
Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

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		La Mesa	California	91942	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
26773446	Background	Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(R) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.
22933438

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
FG001

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

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment

The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Units	Counts
Participants	OG000366 OG001182

Title

Denominators

Categories

Title	Measurements
	OG000-0.73± 0.83 OG001-0.68± 0.77

Secondary

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 26 + 7 days follow up

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 22 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 26

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment

The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 53

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Units	Counts
Participants

Primary

Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 53 + 7 days follow up

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 53 + 7 days follow up

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 26 + 7 days follow up

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment.

The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects, FPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 53

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Units	Counts
Participants

Primary

Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 53 + 7 days of follow up

ID	Title	Description
OG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Pericardial effusion	Cardiac disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Eye haemorrhage	Eye disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Food poisoning	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events2 affected362 at risk EG0010 events0 affected180 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Abscess limb	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Meningitis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Wound infection	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0011 events1 affected180 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA Version 13.0	Systematic Assessment	EG0002 events1 affected362 at risk EG0010 events0 affected180 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA Version 13.0	Systematic Assessment	EG0002 events2 affected362 at risk EG0010 events0 affected180 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events1 affected362 at risk EG0013 events3 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG00025 events15 affected362 at risk EG0019 events9 affected180 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG0003 events2 affected362 at risk EG0011 events1 affected180 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG0007 events7 affected362 at risk EG0014 events4 affected180 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events2 affected362 at risk EG0010 events0 affected180 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0011 events1 affected180 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events1 affected362 at risk EG0010 events0 affected180 at risk
Migraine	Nervous system disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Depression	Psychiatric disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events2 affected362 at risk EG0010 events0 affected180 at risk
Suicidal ideation	Psychiatric disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0011 events1 affected180 at risk
Suicide attempt	Psychiatric disorders	MedDRA Version 13.0	Systematic Assessment	EG0002 events1 affected362 at risk EG0010 events0 affected180 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 events0 affected362 at risk EG0011 events1 affected180 at risk
Victim of crime	Social circumstances	MedDRA Version 13.0	Systematic Assessment	EG0001 events1 affected362 at risk EG0010 events0 affected180 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C578220	insulin degludec, insulin aspart drug combination
D000069057	Insulin Detemir
D061267	Insulin Aspart

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061266	Insulin, Short-Acting

ID	Title	Description
BG000	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
BG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension 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	IDegAsp OD	Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.			46	362	166	362
EG001	IDet	Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.			20	180	90	180

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG00014 events13 affected362 at risk EG00112 events12 affected180 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 13.0	Systematic Assessment	EG00024 events14 affected362 at risk EG00110 events9 affected180 at risk
Injection site reaction	General disorders	MedDRA Version 13.0	Systematic Assessment	EG0008 events5 affected362 at risk EG00136 events9 affected180 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG00015 events14 affected362 at risk EG00110 events9 affected180 at risk
Influenza	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG00025 events25 affected362 at risk EG00112 events9 affected180 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG000139 events89 affected362 at risk EG00162 events38 affected180 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG00048 events33 affected362 at risk EG00130 events20 affected180 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG00040 events29 affected362 at risk EG00150 events24 affected180 at risk
Headache	Nervous system disorders	MedDRA Version 13.0	Systematic Assessment	EG000102 events35 affected362 at risk EG00122 events16 affected180 at risk