Long-term, Open-label Follow-up Treatment of Patients Wit... | NCT00157248

Label	Type	Description	Intervention Names
dabigatran etexilate, 150 mg once daily	Experimental	dosage used at study start	Drug: dabigatran etexilate
dabigatran etexilate, 150 mg twice daily	Experimental	dosage used at study start	Drug: dabigatran etexilate
dabigatran etexilate, 300 mg once daily	Experimental	dosage used at study start	Drug: dabigatran etexilate
dabigatran etexilate, 300 mg twice daily	Experimental	dosage used at study start	Drug: dabigatran etexilate

Name	Type	Description	Arm Group Labels	Other Names
dabigatran etexilate	Drug	dosage used at study start	dabigatran etexilate, 150 mg once daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.	Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25	5 years
Yearly Event Rate for Major Bleeding	Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25	5 years
Yearly Event Rate for Major + Minor/Relevant Bleeding	Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25	5 years
Yearly Event Rate for Any Bleeding	Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25	5 years
Yearly Event Rate for Minor Bleeding	Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds. Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Secondary Outcomes

Measure	Description	Time Frame
Yearly Event Rate for Stroke	Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25	5 years
Yearly Event Rate of Ischaemic Stroke

Eligibility Module

Eligibility Criteria

Inclusion criteria Diagnosis and main criteria for inclusion: Paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation with a history of coronary artery disease (CAD)

Inclusion Criteria:

previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy
paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO
concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years
written, informed consent

Exclusion criteria

Exclusion Criteria:

Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study.
contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage).
severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg).
Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study).
Patients who have received an investigational drug other than BIBR 1048 within the last 30 days.
Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. Another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). Clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a GI bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). Patients suffering from thrombocytopenia (platelets < 100,000/uL). Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
Continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (ASA).
Recent malignancy or radiation therapy (<= 6 months).

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1160.42.10003 Boehringer Ingelheim Investigational Site		La Mesa	California		United States
1160.42.10006 Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dabigatran Etexilate, 150 mg QD (Once Daily)	Dosage used at study start
FG001	Dabigatran Etexilate, 150 mg BID (Twice Daily)	Dosage used at study start

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.

Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003	150 mg Twice Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
OG004	300 mg Once Daily	Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
OG005	300 mg Twice Daily	Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily

Units	Counts
Participants	OG0001 OG001105 OG002102 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.0 OG00117.0 OG0025.0 OG003

Secondary

Yearly Event Rate for Stroke

Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate of Ischaemic Stroke

Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate of Haemorrhagic Stroke

Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate for Transient Ischaemic Attacks

Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate for Systemic Thromboembolism

Time to first occurrence of any non-central nervous system systemic thromboembolism.

Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily

Secondary

Yearly Event Rate of Myocardial Infarction

Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate of Other Major Adverse Cardiac Events

Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate of Death

Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003	150 mg Twice Daily

Primary

Yearly Event Rate for Major Bleeding

Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.

Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily

Primary

Yearly Event Rate for Major + Minor/Relevant Bleeding

Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Primary

Yearly Event Rate for Any Bleeding

Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003

Secondary

Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality

Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.

Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily

Secondary

Severe Adverse Event

Frequency of patients with severe adverse events.

All treated patients.

Posted

Number

participants

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003	150 mg Twice Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
OG004	300 mg Once Daily	Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily

Primary

Yearly Event Rate for Minor Bleeding

Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.

Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.

Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

Posted

Number

yearly event rate (percentage)

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily

Secondary

Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.

Normal ranges are defined as:

Alanine aminotransferase (ALT): 5-45 [U/L]
Aspartate aminotransferase (AST): 10-40 [U/L]
Bilirubin, total: 0.2-1.0 [mg/dL]

All treated patients.

Posted

Number

participants

5 years

ID	Title	Description
OG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
OG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
OG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
OG003	150 mg Twice Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG0039 affected356 at risk EG0041 affected90 at risk EG0050 affected161 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Atrial conduction time prolongation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cardiac asthma	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0022 affected102 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0022 affected102 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Palpitations	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Retinal detachment	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Peritonitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Drug ineffective	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Dysplasia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
General physical health deterioration	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Impaired healing	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Malaise	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Sudden cardiac death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Sudden death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Endocarditis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Erysipelas	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gangrene	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Implant site infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Localised infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Meningitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Nail infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Skin infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Urosepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Stent-graft endoleak	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Blood creatinine increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Blood pressure systolic inspiratory decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Electrocardiogram ST segment depression	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Heart rate increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Heart rate irregular	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Liver function test abnormal	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0021 affected102 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0023 affected102 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Migraine	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Myasthenic syndrome	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Syncope	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Delirium	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Albuminuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Calculus urethral	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Urethral haemorrhage	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Urinary tract disorder	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Prostatism	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Joint prosthesis user	Social circumstances	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Aneurysm	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Femoral artery aneurysm	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Femoral artery occlusion	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Temporal arteritis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Vasculitis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Wound haemorrhage	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG00321 affected356 at risk EG0043 affected90 at risk EG0052 affected161 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0021 affected102 at risk EG003
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0021 affected102 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0017 affected105 at risk EG0022 affected102 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0019 affected105 at risk EG0024 affected102 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0013 affected105 at risk EG0022 affected102 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0013 affected105 at risk EG0022 affected102 at risk EG003
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0021 affected102 at risk EG003
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0024 affected102 at risk EG003
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0013 affected105 at risk EG0026 affected102 at risk EG003
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0022 affected102 at risk EG003
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0021 affected102 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0013 affected105 at risk EG0025 affected102 at risk EG003
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0022 affected102 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0021 affected102 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0022 affected102 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0013 affected105 at risk EG0022 affected102 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0023 affected102 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0023 affected102 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0027 affected102 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0020 affected102 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0014 affected105 at risk EG0024 affected102 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0017 affected105 at risk EG0024 affected102 at risk EG003
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0016 affected105 at risk EG0023 affected102 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0021 affected102 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0022 affected102 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0025 affected102 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0026 affected102 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0023 affected102 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0021 affected102 at risk EG003
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0011 affected105 at risk EG0021 affected102 at risk EG003
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0012 affected105 at risk EG0025 affected102 at risk EG003
Varicose vein	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected1 at risk EG0010 affected105 at risk EG0020 affected102 at risk EG003

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Dabigatran Etexilate, 150 mg QD (Once Daily)	Dosage used at study start
BG001	Dabigatran Etexilate, 150 mg BID (Twice Daily)	Dosage used at study start
BG002	Dabigatran Etexilate, 300 mg QD (Once Daily)	Dosage used at study start
BG003	Dabigatran Etexilate, 300 mg BID (Twice Daily)	Dosage used at study start
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	50 mg Once Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily	0	1	0	1
EG001	50 mg Twice Daily	Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily	8	105	18	105
EG002	150 mg Once Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily	20	102	17	102
EG003	150 mg Twice Daily	Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily	153	356	219	356
EG004	300 mg Once Daily	Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily	39	90	65	90
EG005	300 mg Twice Daily	Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily	21	161	57	161