Tiotropium / Respimat One Year Study in COPD. | NCT00387088

NCT00387088

ID	Type	Description	Link
2006-001009-27

Status 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
Tiotropium	Other	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Drug: Tiotropium
Placebo	Other	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Device: Respimat

Name	Type	Description	Arm Group Labels	Other Names
Respimat	Device		Placebo
Tiotropium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337	Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).	Baseline and Day 337
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation	Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.	During actual study treatment period (planned Day 1 to Day 337)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29	Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.	Baseline and Day 29
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
205.372.01012 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
205.372.01020 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32943047	Derived	Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.
20620037	Derived	Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
BG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
BG002	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

The TS was made up of all randomised and treated participants excluding 74 patients with potential fraudulent data from one investigator site

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG0000.119± 0.007 OG0010.018± 0.007

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	ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.	<0.0001		Mean Difference (Final Values)	0.102	Standard Error of the Mean	0.009	2-Sided	95	0.085	0.118				No	Superiority or Other

Primary

Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

95% Confidence Interval

Days

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29

Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.

Posted

Least Squares Mean

Standard Error

Litres

Baseline and Day 29

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169

Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.

Posted

Least Squares Mean

Standard Error

Litres

Baseline and Day 169

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Number of COPD Exacerbations Per Patient - Exposure Adjusted

Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

Full Range

COPD exacerbations per year

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants

Secondary

Number of COPD Exacerbations Per Patient - naïve Estimate

Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

Full Range

COPD exacerbations

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Number of Patients With at Least One COPD Exacerbation

Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Number

participants

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Time to First Hospitalisation for COPD Exacerbation

Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

95% Confidence Interval

Days

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted

Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

Full Range

hospitalisations for COPD exacerbations

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants

Secondary

Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate

Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Median

Full Range

hospitalisations for COPD exacerbations

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants

Secondary

Number of Patients With at Least One Hospitalisation for a COPD Exacerbation

Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Posted

Number

participants

During actual study treatment period (planned Day 1 to Day 337)

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337

The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and Day 337

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169

The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and Day 169

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337

The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and Day 337

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169

The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and Day 169

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.

Posted

Least Squares Mean

Standard Error

Litres

Baseline and Day 29

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.

Posted

Least Squares Mean

Standard Error

Litres

Baseline and Day 169

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337

Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.

Posted

Least Squares Mean

Standard Error

Litres

Baseline and Day 337

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Secondary

Marked Changes From Baseline in Vital Signs at End of Treatment

Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.

Treated set

Posted

Number

participants

Baseline and end of treatment

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants

Secondary

Clinically Relevant Findings in Physical Examination and ECG

Clinically relevant findings in Physical Examination and ECG at end of treatment

Treated set

Posted

Number

participants

End of treatment

ID	Title	Description
OG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
OG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tiotropium	Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)			342	1,952	866	1,952
EG001	Placebo	Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)			336	1,965	926	1,965

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0015 affected1,965 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0013 affected1,965 at risk
Angina unstable	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0015 affected1,965 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Atrial flutter	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Atrioventricular block	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Bradycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cardiac arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0008 affected1,952 at risk EG00110 affected1,965 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0014 affected1,965 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0011 affected1,965 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cor pulmonale	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0013 affected1,965 at risk
Cor pulmonale acute	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0012 affected1,965 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Left ventricular failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0015 affected1,965 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0010 affected1,965 at risk
Palpitations	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pericardial effusion	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Pericarditis	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Right ventricular failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cataract	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Retinal artery occlusion	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Ascites	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Chilaiditi's syndrome	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0015 affected1,965 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,952 at risk EG0016 affected1,965 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Melaena	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Proctocolitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Volvulus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Asthenia	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Chest discomfort	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Chest pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0010 affected1,965 at risk
Death	General disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0011 affected1,965 at risk
Drowning	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Drug interaction	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Malaise	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Mass	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Oedema peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Pitting oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Polyp	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Sudden death	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cholecysititis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Cholecysititis acute	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0013 affected1,965 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Abscess intestinal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Acute sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Appendicitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0007 affected1,952 at risk EG0016 affected1,965 at risk
Bronchopneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0014 affected1,965 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Bursitis infective	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cystitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Diverticulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Empyema	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Endocarditis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Epiglottitis haemophilus	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Febrile infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0016 affected1,965 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Herpes zoster	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0013 affected1,965 at risk
Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0009 affected1,952 at risk EG00118 affected1,965 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0017 affected1,965 at risk
Localised infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0016 affected1,965 at risk
Lung infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Osteomyelitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00026 affected1,952 at risk EG00137 affected1,965 at risk
Postoperative wound infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Rectal abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0012 affected1,965 at risk
Septic shock	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Staphylococcal infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Tuberculosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0014 affected1,965 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0011 affected1,965 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0011 affected1,965 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Alanine aminotransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Blood alcohol increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Blood glucose increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Blood pressure increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Chest x-ray abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Prostatic specific antigen increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Weight decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Benigh neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0010 affected1,965 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0011 affected1,965 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0013 affected1,965 at risk
Hypopharyngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG00010 affected1,952 at risk EG0012 affected1,965 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Metastases to skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Ataxia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cerebral circulatory failure	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cerebral infarction	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0012 affected1,965 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Cervical myelopathy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Convulsion	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Dementia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Dysarthria	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hemiplegia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Lethargy	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Loss of consciousness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Monoparesis	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Presyncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Sciatica	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Somnolence	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Syncope	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Syncope vasovagal	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0013 affected1,965 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Vascular dementia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Completed suicide	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Confusional state	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0012 affected1,965 at risk
Delirium	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Stress	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Suicide attempt	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Incontinence	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0011 affected1,965 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0005 affected1,952 at risk EG0011 affected1,965 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,952 at risk EG0013 affected1,965 at risk
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 affected1,952 at risk EG0013 affected1,965 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000130 affected1,952 at risk EG001155 affected1,965 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG00010 affected1,952 at risk EG0014 affected1,965 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0013 affected1,965 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0011 affected1,965 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0011 affected1,965 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 affected1,952 at risk EG0017 affected1,965 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0012 affected1,965 at risk
Pulmonary fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 affected1,952 at risk EG0011 affected1,965 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0010 affected1,965 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0009 affected1,952 at risk EG00111 affected1,965 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Lichen nitidus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Living in residential institution	Social circumstances	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Gallbladder operation	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hysterectomy	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Ileostomy closure	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Shoulder arthroplasty	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Urethrotomy	Surgical and medical procedures	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Aortic aneurysm	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Aortic rupture	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Aortic stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Arterial stenosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Arteriosclerosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Haemorrhage	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hypertensive crisis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 affected1,952 at risk EG0012 affected1,965 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Intermittent claudication	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected1,952 at risk EG0010 affected1,965 at risk
Phlebitis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Venous insufficiency	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected1,952 at risk EG0011 affected1,965 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG000157 affected1,952 at risk EG001151 affected1,965 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00097 affected1,952 at risk EG001123 affected1,965 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000561 affected1,952 at risk EG001659 affected1,965 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000122 affected1,952 at risk EG001144 affected1,965 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG000123 affected1,952 at risk EG001106 affected1,965 at risk

Ancestor Terms

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D009930	Organic Chemicals
D000470	Alkaloids
D006571	Heterocyclic Compounds
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring

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