Patient Convenience Study | NCT02597920

Status Module

Label	Type	Description	Intervention Names
Switch patients / A		Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
New AF patients / B		Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment	The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).	Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups	The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.	Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).

Secondary Outcomes

Measure	Description	Time Frame
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment	The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1160.247.1019 Boehringer Ingelheim Investigational Site		Braine-l'Alleud			Belgium
1160.247.1001 Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 17, 2015	Jan 25, 2018

Arm/Group Information

ID	Title	Description
BG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
BG001	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
BG002	Cohort B VKA	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age (mean and standard deviation (SD)) at the time of signing informed consent form is presented.

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00073.3± 8.9 BG00172.7± 9.1 BG00274.9± 10.1 BG003

Age, Customized

Number of participants are presented by age categories.

Number

Participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG00083 BG001207 BG002

Sex: Female, Male

Number of subjects are categorized as Male or Female by each cohort.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000258 BG001520 BG002

Race/Ethnicity, Customized

Race and ethnicity was not collected under study protocol.

Number

Participants

Title

Denominators

Categories

Title	Measurements
	BG000NARace and ethnicity was not collected under study protocol. BG001NARace and ethnicity was not collected under study protocol.

Region of Enrollment

Number of subjects are presented by region. Northern European countries included Belgium, Denmark, Norway, Sweden and The Netherlands while the Southern European countries included Greece and Portugal.

Number

Participants

Title

Denominators

Categories

Northern Europe

Title	Measurements
	BG000252 BG001

Creatinine clearance at baseline

Number of subjects are presented for different categories of creatinine.

Number

Participants

Title

Denominators

Categories

<30 milliliter per minute (mL/min)

Title	Measurements
	BG0000 BG0010 BG002

CHA2DS2-VASc stroke risk score at baseline

CHA2DS2-VASc score: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes mellitus, Stroke/Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category.

Number

Participants

Title

Denominators

Categories

Intermediate risk (score = 1)

Title	Measurements
	BG00048 BG001

HAS-BLED bleeding risk score at baseline

HAS-BLED score: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol.

Number

Participants

Title

Denominators

Categories

Low risk (score < 3)

Title	Measurements
	BG000388 BG001

Speciality of treating physician

Number of subjects treated by different physicians are presented

Number

Participants

Title

Denominators

Categories

Cardiologist

Title	Measurements
	BG000548 BG0011087 BG002

Type of hospital or practise

Number of subjects treated at different type of facilities

Number

Participants

Title

Denominators

Categories

Public

Title	Measurements
	BG000207 BG001387 BG002

Owner of medical practice

Number of subjects are presented by owner of medical practice

Number

Participants

Title

Denominators

Categories

Physician or physician group

Title	Measurements
	BG000390 BG001783 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment

The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.

Posted

Mean

Standard Deviation

Units on Scale

Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).

Units	Counts
Participants	OG000585

Title

Denominators

Categories

CDS-Baseline

- ParticipantsOG000583

Title	Measurements
	OG00063.4± 25.2

CDS-Visit 2

- ParticipantsOG000

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	Within group comparison of Baseline CDS with that of Visit 2.	Paired t-test		<0.0001														Other
OG000	Within group comparison of Baseline CDS with that of Visit 3.	Paired t-test

Primary

Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups

The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.

Posted

Mean

Standard Deviation

Units on Scale

Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).

ID	Title	Description
OG000	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).

Primary

Patient Characterization at Baseline - Categorical Parameters

Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

Posted

Number

Percentage of participants

Baseline

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG001	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG002	Cohort B VKA

Primary

Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score

CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

Posted

Mean

Standard Deviation

Units on scale

Baseline

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG001	Cohort B Pradaxa®

Primary

Patient Characterization at Baseline - Creatinine Clearance

Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

Posted

Mean

Standard Deviation

millilitre/ minute [mL/min]

Baseline

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG001	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG002	Cohort B VKA	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.

Primary

Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration

Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

Posted

Mean

Standard Deviation

Years

Baseline

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG001	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).
OG002	Cohort B VKA	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.

Secondary

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

Posted

Mean

Standard Deviation

Units on Scale

Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).

ID	Title	Description
OG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).

Secondary

Description of PACT-Q1 Items for Patients in Cohort B at Baseline

The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).

Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q1 score at Visit 1 obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary.

Posted

Mean

Standard Deviation

Units on scale

Baseline

ID	Title	Description
OG000	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Cohort A Pradaxa®	Patients with a diagnosis of non-valvular atrial fibrillation (NVAF), who were using Vitamin K antagonist (VKA) therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) twice daily dose of Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).	1	585	4	585	585
EG001	Cohort B Pradaxa®	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on twice daily dose of 110 or 150 mg Pradaxa® hard capsules containing Dabigatran etexilate (active ingredient: Dabigatran).	5	1,159	8	1,159	1,159
EG002	Cohort B VKA	Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	1	78	2	78	78

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected585 at risk EG0010 affected1,159 at risk EG0020 affected78 at risk
Septic shock	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected585 at risk EG0010 affected1,159 at risk EG0020 affected78 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected585 at risk EG0010 affected1,159 at risk EG0020 affected78 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0010 affected1,159 at risk EG0021 affected78 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0021 affected78 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk
Haemorrhage	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected585 at risk EG0011 affected1,159 at risk EG0020 affected78 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms