A Randomized, Double-Blind, Parallel-Group, 24-Week, Chro... | NCT02497001

Label	Type	Description	Intervention Names
BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator	Experimental	BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: BGF MDI 320/14.4/9.6 μg
GFF MDI (PT003) 14.4/9.6 μg ex-actuator	Experimental	GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: GFF MDI (PT003) 14.4/9.6 μg
BFF MDI (PT009) 320/9.6 μg ex-actuator	Experimental	BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol	Drug: BFF MDI (PT009) 320/9.6 μg
Symbicort	Active Comparator	Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg	Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder

Name	Type	Description	Arm Group Labels	Other Names
BGF MDI 320/14.4/9.6 μg	Drug	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])	BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator

Measure	Description	Time Frame
FEV1 AUC0-4	FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).	at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand	at Week 24

Measure	Description	Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand	over 24 Weeks
Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing	Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand

Name	Affiliation	Role
Paul Dorinsky, MD	Pearl Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Andalusia	Alabama	36420	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
41237914	Derived	Patel M, Marshall J, Martinez FJ, Mushunje A, Bowen K, Jenkins M. Frequent productive cough in COPD relates to exacerbation risk and treatment benefit from budesonide/glycopyrrolate/formoterol fumarate: a post hoc analysis of KRONOS. Respir Med. 2025 Dec;250:108499. doi: 10.1016/j.rmed.2025.108499. Epub 2025 Nov 12.
40340809	Derived

Label	URL
Related Info	View source

ID	Title	Description
FG000	BGF MDI 320/14.4/9.6 ug	Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug
FG001	GFF MDI 14.4/9.6 ug	Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jan 9, 2018	Mar 26, 2020

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

FEV1 AUC0-4

FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).

mITT population total numbers may vary based on predefined subject exclusions prior to study unblinding

Posted

Least Squares Mean

95% Confidence Interval

Liters

at Week 24

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts
Participants	OG000436 OG001403 OG002201 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.292(0.271 to 0.314) OG0010.288(0.266 to 0.310) OG0020.177(0.146 to 0.207) OG003

Primary

Change From Baseline in Morning Pre-dose Trough FEV1

Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

at Week 24

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Change From Baseline in Morning Pre-dose Trough FEV1

Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

over 24 Weeks

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing

Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

at Week 24

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units

Secondary

Rate of Moderate or Severe COPD Exacerbations

Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand

mITT

Posted

Least Squares Mean

Standard Error

Exacerbations

over 24 weeks

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)

Change from BGF

mITT

Posted

Least Squares Mean

95% Confidence Interval

Percentage

at Week 24

ID	Title	Description
OG000	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG001	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG002	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Average Daily Rescue Ventolin HFA Use

Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Puffs

over 24 Weeks

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Secondary

Time to Onset of Action on Day 1, 5 Minutes Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Time to Onset of Action on Day 1, 15 Minutes Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Time to Onset of Action on Day 1, 30 Minutes Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Time to Onset of Action on Day 1, 1 Hour Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Time to Onset of Action on Day 1, 2 Hours Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Secondary

Time to Onset of Action on Day 1, 4 Hours Post Dose

FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand

mITT

Posted

Least Squares Mean

95% Confidence Interval

Liters

Day 1

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 μg	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
OG001	GFF MDI (PT003) 14.4/9.6 μg	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
OG002	BFF MDI (PT009) 320/9.6 μg	Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
OG003	Symbicort®	Symbicort® Turbuhaler® (TBH) Inhalation Powder

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00017 events17 affected639 at risk EG00141 events32 affected625 at risk EG0028 events8 affected314 at risk EG00316 events13 affected318 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected639 at risk EG0012 events1 affected625 at risk EG0021 events1 affected314 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected639 at risk EG0016 events6 affected625 at risk EG0021 events1 affected314 at risk EG003
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected625 at risk EG0021 events1 affected314 at risk EG003
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0021 events1 affected314 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Dengue ferver	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Diverticulitits	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Gastritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Lymphangitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Meningitis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0012 events2 affected625 at risk EG0021 events1 affected314 at risk EG003
Coronary artery disease	Cardiac disorders	medDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected625 at risk EG0021 events1 affected314 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Atrial fibrilation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Cardiac failure tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	nedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Acute myeloid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Malignant neoplasm of thymus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Metasteses of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Metasteses to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Urethral cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Cerebral ischeamia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Cerebrovascular insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Siezure	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events2 affected625 at risk EG0020 events0 affected314 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Large intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Road traffic accident6	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Death	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0021 events1 affected314 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0021 events1 affected314 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0012 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Delerium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Electrocardiogram T wave inversion	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected639 at risk EG0010 events0 affected625 at risk EG0020 events0 affected314 at risk EG003
Myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected639 at risk EG0011 events1 affected625 at risk EG0020 events0 affected314 at risk EG003

ID	Title	Description
BG000	BGF MDI 320/14.4/9.6 ug	Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug
BG001	GFF MDI 14.4/9.6 ug	Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug
BG002	BFF MDI 320/9.6 ug	Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 ug
BG003	Symbicort TBH 400/12 ug	Symbicort Turbuhaler 400/12 ug
BG004	Total	Total of all reporting groups

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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BGF MDI 320/14.4/9.6 ug	Budesonide Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 ug	6	639	55	639	126	639
EG001	GFF MDI 14.4/9.6 ug	Glycopyrronium Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 ug	3	625	68	625	84	625
EG002	BFF MDI 320/9.6 ug	Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 ug	2	314	21	314	59	314
EG003	Symbicort TBH 400/12 ug	Symbicort Turbuhaler 400/12 ug	1	318	29	318	55	318

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitits	Infections and infestations	MedDRA	Systematic Assessment	EG00061 events49 affected639 at risk EG00148 events41 affected625 at risk EG00230 events26 affected314 at risk EG00332 events30 affected318 at risk
Upper Respiratory Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00077 events65 affected639 at risk EG00141 events37 affected625 at risk EG00218 events18 affected314 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 events21 affected639 at risk EG0019 events8 affected625 at risk EG00218 events17 affected314 at risk EG003