Local Phase 4 Pan-European SMART Study | NCT00463866

Name	Type	Description	Arm Group Labels	Other Names
Budesonide/formoterol	Drug

Measure	Description	Time Frame
Number of Severe Asthma Exacerbations Per Participant.	Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.	6 months

Measure	Description	Time Frame
Fraction of Participants With Severe Asthma Exacerbation	The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.	6 months.

Name	Affiliation	Role
Michel Aubier, Prof	FRANCE	Principal Investigator
Juliette Ostinelli, MD	AstraZeneca, MC France	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aalst			Belgium
Research Site

PubMed Identifier	Type	Citation	Retractions
21586508	Derived	Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
21435854	Derived

ID	Title	Description
FG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
FG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

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

Number of Severe Asthma Exacerbations Per Participant.

Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Posted

Mean

Full Range

Severe exacerbations per participant

6 months

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG0004008 OG0014045

Title

Denominators

Categories

Title	Measurements
	OG0000.097± 0(0 to 4) OG0010.080± 0(0 to 5)

Secondary

Fraction of Participants With Severe Asthma Exacerbation

The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Posted

Mean

95% Confidence Interval

Fraction of participants with event

6 months.

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.

A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant

Posted

Mean

Full Range

Number of events per participant

6 months.

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation

Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Posted

Mean

Standard Deviation

Days per participant

6 months.

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Mean Daily Number of Inhalations of As-needed Medication.

The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.

Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group

Posted

Mean

Full Range

Inhalations per day per participant

4 weeks

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Percent of Participants With a Well Controlled Asthma Week.

The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.

Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.

Posted

Mean

Full Range

Percentage of participants

6 months.

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Mean Overall Asthma Control Questionnaire (ACQ) Score

The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.

Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.

Posted

Mean

Full Range

Scores in a scale

6 months.

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

The Mean Total Daily Dose of Steroids From Symbicort.

The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.

: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.

Posted

Mean

Standard Deviation

μg budesonide per day

4 weeks

ID	Title	Description
OG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
OG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.

Units	Counts
Participants	OG000

Secondary

Mean Cost Per Participant Per Country

Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.

Not Posted

Mean

Full Range

Euro

6 months

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Angina Pectoris	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected4,008 at risk EG0011 affected4,045 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Exomphalos	Congenital, familial and genetic disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Cataract	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0012 affected4,045 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Colitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected4,008 at risk EG0010 affected4,045 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected4,008 at risk EG0010 affected4,045 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Reflux Oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Salivary Gland Enlargement	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected4,008 at risk EG0011 affected4,045 at risk
Cyst	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0014 affected4,045 at risk
Food Allergy	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Sarcoidosis	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Appendicitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Bronchiectasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0012 affected4,045 at risk
Campylobacter Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Chronic Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Epstein-Barr Virus Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Erysipelas	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Lung Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Meningitis Viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Pilonidal Cyst	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected4,008 at risk EG0013 affected4,045 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Tonsillitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Tracheobronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Animal Bite	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0012 affected4,045 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Multiple Drug Overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Traumatic Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0012 affected4,045 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0012 affected4,045 at risk
Muscle Mass	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected4,008 at risk EG0013 affected4,045 at risk
Spinal Disorder	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0014 affected4,045 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Parathyroid Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Vocal Cord Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Carotid Sinus Syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0012 affected4,045 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Ischaemic Cerebral Infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Migraine	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00013 affected4,008 at risk EG0019 affected4,045 at risk
Asthmatic Crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0012 affected4,045 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Pharyngeal Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0011 affected4,045 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected4,008 at risk EG0012 affected4,045 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0011 affected4,045 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected4,008 at risk EG0010 affected4,045 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000068759	Formoterol Fumarate
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D019819	Budesonide
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
BG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
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	Symbicort® SMART®) 1*2	1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.			77	4,008	0	4,008
EG001	Symbicort® SMART®) 2*2	2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.			88	4,045	0	4,045

ID	Type	Description	Link
EUROSMART
EudraCTNo. 2006-006512-30