A Comparison of SYMBICORT® pMDI With Formoterol Turbuhale... | NCT00419744

Official Title

A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year	Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.	12 months
Rate of Exacerbations Per Subject-year	Rate of exacerbations per subject-year	12 months

Secondary Outcomes

Measure	Description	Time Frame
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.	12 months
Morning Peak Expiratory Flow (PEF)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Christer Hultquist, MD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Jasper	Alabama		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29331313	Derived	Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
26293575

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
FG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
BG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
BG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
BG003	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
	OG0000.75 OG0010.84 OG0021.14

Secondary

Pre-dose Forced Expiratory Volume in 1 Second (FEV1)

Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.

Posted

Mean

Standard Deviation

Liters (L)

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants	OG000

Secondary

Morning Peak Expiratory Flow (PEF)

Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.

Posted

Mean

Standard Deviation

L/min

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants	OG000

Secondary

Evening PEF

Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.

Posted

Mean

Standard Deviation

L/min

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants	OG000

Secondary

Dyspnea Symptom Scores

Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.

Posted

Mean

Standard Deviation

Scores on a scale

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants

Secondary

Use of Rescue Medication

Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.

Posted

Mean

Standard Deviation

Number of inhalations

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants	OG000

Secondary

St. George's Respiratory Questionnaire (SGRQ) Score

Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.

Posted

Mean

Standard Deviation

Scores on a scale

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts

Primary

Rate of Exacerbations Per Subject-year

Rate of exacerbations per subject-year

Posted

Number

Rate

12 months

ID	Title	Description
OG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
OG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
OG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SYM 160/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)	79	407	193	407
EG001	SYM 80/4.5 X 2 BID	SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID	61	408	177	408
EG002	FOR 4.5 X 2 BID	Formoterol Turbuhaler 4.5 μg x 2 inhalations BID	73	403	176	403

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected407 at risk EG0013 affected408 at risk EG0020 affected403 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0023 affected403 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0022 affected403 at risk
Cor Pulmonale	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0022 affected403 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0012 affected408 at risk EG0020 affected403 at risk
Angina Pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Atrial Flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Angina Unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Cardiac Failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0022 affected403 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0021 affected403 at risk
Abdominal Hernia Obstructive	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Gastroduodenal Ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Multi-Organ Failure	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Sudden Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0012 affected408 at risk EG0021 affected403 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Jaundice Cholestatic	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00013 affected407 at risk EG0014 affected408 at risk EG0027 affected403 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0023 affected403 at risk
Upper Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0012 affected408 at risk EG0020 affected403 at risk
Appendicitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Bronchitis Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Dengue Fever	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Enterocolitis Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Pneumonia Viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Hepatitis A	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Lower Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Anal Abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Gangrene	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Septic Shock	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Drug Toxicity	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Collapse Of Lung	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Dislocation Of Joint Prosthesis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0021 affected403 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Foot Fracture	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Metastatic Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Non-Small Cell Lung Cancer Stage Iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Oesophageal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Oesophageal Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Mesothelioma Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Convulsion	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0021 affected403 at risk
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Renal Aneurysm	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Renal Mass	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00032 affected407 at risk EG00133 affected408 at risk EG00234 affected403 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected407 at risk EG0012 affected408 at risk EG0021 affected403 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected407 at risk EG0012 affected408 at risk EG0020 affected403 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Bronchial Secretion Retention	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Laryngeal Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk
Accelerated Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0010 affected408 at risk EG0021 affected403 at risk
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected407 at risk EG0010 affected408 at risk EG0020 affected403 at risk
Intermittent Claudication	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected407 at risk EG0011 affected408 at risk EG0020 affected403 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00031 affected407 at risk EG00135 affected408 at risk EG00241 affected403 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00037 affected407 at risk EG00132 affected408 at risk EG00225 affected403 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00029 affected407 at risk EG00126 affected408 at risk EG00225 affected403 at risk
Upper Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00018 affected407 at risk EG00123 affected408 at risk EG00217 affected403 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00021 affected407 at risk EG00113 affected408 at risk EG00214 affected403 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG00021 affected407 at risk EG00118 affected408 at risk EG00221 affected403 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00056 affected407 at risk EG00146 affected408 at risk EG00243 affected403 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00057 affected407 at risk EG00146 affected408 at risk EG00268 affected403 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG00021 affected407 at risk EG00116 affected408 at risk EG0029 affected403 at risk

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Ancestor Terms

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

ID	Term
D019819	Budesonide
D000068759	Formoterol Fumarate
D000069502	Budesonide, Formoterol Fumarate Drug Combination

Name	Type	Description	Arm Group Labels	Other Names
Budesonide/formoterol (SYMBICORT) pMDI	Drug
Formoterol Turbuhaler	Drug