Efficacy, Safety, and Tolerability of Aclidinium Bromide... | NCT01045161

Status Module

Oversight Module

Description 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
1	Experimental	Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks	Drug: Aclidinium bromide
2	Experimental	Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks	Drug: Aclidinium bromide
3	Placebo Comparator	Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aclidinium bromide	Drug	Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)	Change from baseline (Week 0) to Week 12
Part B: Morning Predose (Trough) FEV1	Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)	Change from baseline (Week 0) to 52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)	Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)	Change from baseline (Week 0) to Week 12
Part B: Peak FEV1

Eligibility Module

Name	Affiliation	Role
Esther Garcia, Ph. D.	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 1493		Birmingham	Alabama	35209	United States
Forest Investigative Site 1419

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24085591	Derived	Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.

Label	URL
las-md-38-synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B	Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Baseline characteristics for Part B are based on participant totals of 147, 154 and 147

Arm/Group Information

ID	Title	Description
BG000	Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B	Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial. After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
BG001	Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B	Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial. After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
BG002	Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B	Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial. After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Part A

Title	Measurements
	BG00061.7± 9.3 BG00163.4± 8.5 BG00263.2± 9.0 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

≥ 40 to < 60 years - Part A

Title	Measurements
	BG00072 BG00157 BG002

Gender

Part A

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00082 BG00184 BG002

Gender

Part B

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00082 BG00184 BG002

Region of Enrollment

Part A

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000180 BG001181 BG002

Region of Enrollment

Part B

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000145 BG001152 BG002

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

Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.

Posted

Least Squares Mean

Standard Error

Change from baseline (Week 0) to Week 12

ID	Title	Description
OG000	Placebo	Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
OG001	Aclidinium Bromide 200 μg	Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
OG002	Aclidinium Bromide 400 μg	Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.

Units	Counts
Participants	OG000182 OG001182 OG002177

Title

Denominators

Categories

Title	Measurements
	OG000-0.008± 0.015 OG0010.043± 0.015 OG0020.064± 0.016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.019		Least Squares Mean Difference	0.051			2-Sided	95	0.01	0.09				No	Superiority or Other
OG000 OG002		ANCOVA		0.0012

Secondary

Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)

Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)

Posted

Least Squares Mean

Standard Error

Change from baseline (Week 0) to Week 12

ID	Title	Description
OG000	Placebo	Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
OG001	Aclidinium Bromide 200 μg	Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
OG002	Aclidinium Bromide 400 μg	Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.

Units	Counts
Participants

Primary

Part B: Morning Predose (Trough) FEV1

Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)

A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.

Posted

Mean

Standard Deviation

Change from baseline (Week 0) to 52 Weeks

ID	Title	Description
OG000	Placebo - Aclidinium Bromide 400 μg	Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
OG001	Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg	Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
OG002	Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg

Secondary

Part B: Peak FEV1

Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)

A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.

Posted

Least Squares Mean

Standard Error

Change from baseline (Week 0) to 52 Weeks

ID	Title	Description
OG000	Placebo - Aclidinium Bromide 400 μg	Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
OG001	Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg	Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
OG002	Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg	Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo - Part A	Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.	12	182	22	182
EG001	Aclidinium Bromide 200 μg - Part A	Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.	11	183	20	183
EG002	Aclidinium Bromide 400 μg - Part A	Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.	8	177	28	177
EG003	Placebo to Aclidinium Bromide 400 μg - Part B	After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.	15	147	37	147
EG004	Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B	Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.	20	154	50	154
EG005	Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B	After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.	14	147	52	147

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0006 affected182 at risk EG0015 affected183 at risk EG0025 affected177 at risk EG0034 affected147 at risk EG004
Coronary artery disease	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Bronchitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0021 affected177 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Chest pain	General disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Haematoma	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Hypotension	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Influenza	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Migraine	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Osteomyelitis bacterial	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Vulvar dysplasia	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0021 affected177 at risk EG003
Gastrenteritis salmonella	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0021 affected177 at risk EG003
Pseudomonas bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0010 affected183 at risk EG0021 affected177 at risk EG003
Agitated depression	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected183 at risk EG0020 affected177 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Death	General disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Labyrinthitis	Ear and labyrinth disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Lung adenocarcinoma	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0010 affected183 at risk EG0020 affected177 at risk EG003
Transient ischaemic attack	Vascular disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0011 affected183 at risk EG0020 affected177 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG00021 affected182 at risk EG00116 affected183 at risk EG00223 affected177 at risk EG00324 affected147 at risk EG004
Upper respiratory tract infection	Infections and infestations	MedDRA (13.1)	Systematic Assessment	EG0001 affected182 at risk EG0013 affected183 at risk EG0023 affected177 at risk EG003
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Systematic Assessment	EG0000 affected182 at risk EG0012 affected183 at risk EG0022 affected177 at risk EG003

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D029481	Bronchitis, Chronic
D004646	Emphysema

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
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases