Efficacy, Safety, and Tolerability of Once Daily Indacate... | NCT00393458

NCT00393458

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indacaterol 300 μg plus placebo to formoterol	Experimental	Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol Drug: Placebo to formoterol
Indacaterol 600 μg plus placebo to formoterol	Experimental	Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol Drug: Placebo to formoterol
Formoterol 12 μg plus placebo to indacaterol	Active Comparator	Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol	Drug	Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).	Indacaterol 300 μg plus placebo to formoterol Indacaterol 600 μg plus placebo to formoterol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.	Week 12 + 1 day, Day 85

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Days of Poor Control During 52 Weeks of Treatment	Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Investigator Site	Novartis	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Buenos Aires			Argentina
Novartis

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22206353	Derived	Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
22003288	Derived	Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Indacaterol 300 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Indacaterol 300 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG001	Indacaterol 600 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG002	Formoterol 12 μg Plus Placebo to Indacaterol	Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG003	Placebo to Indacaterol Plus Placebo to Formoterol	Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG004	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

Demographic data are based on all subjects in the safety population, which includes all patients who received at least 1 dose of study drug. Three patients in the indacaterol 600 μg plus placebo to formoterol and one patient in the formoterol 12 μg plus placebo to indacaterol group were not exposed to any study treatment.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001.48± 0.012 OG0011.48± 0.013 OG0021.38± 0.013 OG003

Secondary

Percentage of Days of Poor Control During 52 Weeks of Treatment

Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.

Posted

Least Squares Mean

Standard Error

Percentage of days

Baseline to end of study (Week 52)

ID	Title	Description
OG000	Indacaterol 300 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Indacaterol 300 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	63	437	199	437
EG001	Indacaterol 600 μg Plus Placebo to Formoterol	Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	51	425	183	425
EG002	Formoterol 12 μg Plus Placebo to Indacaterol	Patients inhaled formoterol 12 μg twice daily via the manufacturer's proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	69	434	164	434
EG003	Placebo to Indacaterol Plus Placebo to Formoterol	Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer's proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	48	432	176	432

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG0030 affected432 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0013 affected425 at risk EG0020 affected434 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Microvascular angina	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0012 affected425 at risk EG0021 affected434 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Pericarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Sinus arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Anterior capsule contraction	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0010 affected425 at risk EG0022 affected434 at risk EG003
Macular degeneration	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Retinal artery occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Appendicitis perforated	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Femoral hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Hyperthermia	General disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0012 affected425 at risk EG0025 affected434 at risk EG003
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0022 affected434 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Perianal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected437 at risk EG0012 affected425 at risk EG0025 affected434 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Pyothorax	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0022 affected434 at risk EG003
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0023 affected434 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected437 at risk EG0010 affected425 at risk EG0025 affected434 at risk EG003
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0012 affected425 at risk EG0020 affected434 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Blood creatine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Blood urea increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Colonoscopy	Investigations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Laboratory test abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Benign soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Carcinoid tumour of the small bowel	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Non-small cell lung cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Tracheal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Brain injury	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0021 affected434 at risk EG003
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0022 affected434 at risk EG003
Facial palsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00018 affected437 at risk EG00112 affected425 at risk EG00232 affected434 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected437 at risk EG0010 affected425 at risk EG0025 affected434 at risk EG003
Haemorrhoid operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0020 affected434 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Arteriosclerosis obliterans	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0022 affected434 at risk EG003
Iliac artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0011 affected425 at risk EG0020 affected434 at risk EG003
Shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected437 at risk EG0010 affected425 at risk EG0021 affected434 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00025 affected437 at risk EG00121 affected425 at risk EG00217 affected434 at risk EG00320 affected432 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00073 affected437 at risk EG00180 affected425 at risk EG00262 affected434 at risk EG003
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG00026 affected437 at risk EG00125 affected425 at risk EG00220 affected434 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00023 affected437 at risk EG00125 affected425 at risk EG00212 affected434 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG000128 affected437 at risk EG001108 affected425 at risk EG002112 affected434 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00032 affected437 at risk EG00127 affected425 at risk EG00217 affected434 at risk EG003

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

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

ID	Term
C510790	indacaterol
D000068759	Formoterol Fumarate

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines