Safety, Tolerability and Efficacy of Indacaterol in Patie... | NCT00677807

ID	Type	Description	Link
2008-000663-42	EudraCT Number

Label	Type	Description	Intervention Names
Indacaterol 150 µg	Experimental	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol
Indacaterol 300 µg	Experimental	Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol
Placebo	Placebo Comparator	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol	Drug	Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)	Indacaterol 150 µg Indacaterol 300 µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.	Up to 52 weeks
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.	Up to 52 weeks
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.	Up to 52 weeks
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

Secondary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment	Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.	Week 52

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Homewood	Alabama	35209-6870	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
21349928	Derived	Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B; INDORSE Study Investigators. Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011 Jul;140(1):68-75. doi: 10.1378/chest.10-1830. Epub 2011 Feb 24.

ID	Title	Description
FG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
FG001	Indacaterol 300 µg

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

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.

Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.

High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.

Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.

Posted

Number

Participants

Up to 52 weeks

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Units	Counts
Participants	OG000144 OG001146 OG002124

Title

Denominators

Categories

Low Pulse Rate

Title	Measurements
	OG0003 OG0013 OG0022

High Pulse Rate

Secondary

Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment

Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.

Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.

Posted

Least Squares Mean

Standard Error

Liters

Week 52

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Primary

The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.

A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.

A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.

Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.

Posted

Number

participants

Up to 52 weeks

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo

Primary

The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.

A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.

A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.

Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.

Posted

Number

participants

Up to 52 weeks

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo

Primary

The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.

The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).

Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.

Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.

Posted

Number

participant

Up to 52 weeks

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002

Primary

Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52

The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.

Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. "n" in the categories is the number of participants with data at the given time point for each treatment.

Posted

Least Squares Mean

Standard Error

mmol/L

Weeks 12, 26, 36, 44 and 52

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Primary

Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52

The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.

Posted

Least Squares Mean

Standard Error

mmol/L

Weeks 12, 26, 36, 44 and 52

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Secondary

Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52

The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.

SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.

Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. "n" in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start.

Posted

Least Squares Mean

Standard Error

Score on a Scale

Weeks 36, 44 and 52

ID	Title	Description
OG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
OG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0021 affected124 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Endocardial fibroelastosis	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Faecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0021 affected124 at risk
Pelvic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0022 affected124 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0010 affected146 at risk EG0021 affected124 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected144 at risk EG0015 affected146 at risk EG0023 affected124 at risk
Laryngeal leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Pulmonary calcification	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected144 at risk EG0011 affected146 at risk EG0020 affected124 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected144 at risk EG0010 affected146 at risk EG0020 affected124 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG0015 affected146 at risk EG0027 affected124 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected144 at risk EG0016 affected146 at risk EG0027 affected124 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG0019 affected146 at risk EG0029 affected124 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected144 at risk EG0015 affected146 at risk EG0023 affected124 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG00111 affected146 at risk EG0028 affected124 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00024 affected144 at risk EG00126 affected146 at risk EG00219 affected124 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected144 at risk EG00111 affected146 at risk EG0023 affected124 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected144 at risk EG00120 affected146 at risk EG00210 affected124 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG0018 affected146 at risk EG0024 affected124 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG0018 affected146 at risk EG0021 affected124 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected144 at risk EG0014 affected146 at risk EG0027 affected124 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00012 affected144 at risk EG0014 affected146 at risk EG0022 affected124 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected144 at risk EG0018 affected146 at risk EG0021 affected124 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00015 affected144 at risk EG0017 affected146 at risk EG0025 affected124 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00034 affected144 at risk EG00136 affected146 at risk EG00233 affected124 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00017 affected144 at risk EG00115 affected146 at risk EG0028 affected124 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected144 at risk EG0014 affected146 at risk EG0026 affected124 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected144 at risk EG00110 affected146 at risk EG0022 affected124 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0006 affected144 at risk EG0013 affected146 at risk EG0027 affected124 at risk

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
BG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
BG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
BG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Indacaterol 150 µg	Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	15	144	86	144
EG001	Indacaterol 300 µg	Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	18	146	91	146
EG002	Placebo	Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	13	124	67	124