Trial Outcomes & Findings for Patient Convenience Study (NCT NCT02597920)
NCT ID: NCT02597920
Last Updated: 2019-02-21
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
1852 participants
Primary outcome timeframe
Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Results posted on
2019-02-21
Participant Flow
Non-interventional study (NIS) on patients diagnosed with non-valvular atrial fibrillation (NVAF).
A total of 1852 patients were enrolled, out of which 1822 were found eligible.
Participant milestones
| Measure |
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).
|
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).
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
585
|
1159
|
78
|
|
Overall Study
COMPLETED
|
544
|
1075
|
72
|
|
Overall Study
NOT COMPLETED
|
41
|
84
|
6
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
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.
|
|---|---|---|---|
|
Overall Study
Worsening of other pre-existing disease
|
0
|
1
|
0
|
|
Overall Study
Other adverse event
|
20
|
30
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
0
|
|
Overall Study
Refuse to continue in the study
|
3
|
13
|
1
|
|
Overall Study
Other than specified
|
10
|
31
|
5
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
Patient Convenience Study
Baseline characteristics by cohort
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
Cohort B Pradaxa®
n=1159 Participants
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).
|
Cohort B VKA
n=78 Participants
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.
|
Total
n=1822 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
72.7 Years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
74.9 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
73.0 Years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
|
Age, Customized
< 65 years
|
83 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Age, Customized
≥ 65 and < 75 years
|
213 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
659 Participants
n=4 Participants
|
|
Age, Customized
≥ 75 years
|
289 Participants
n=5 Participants
|
528 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
863 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=5 Participants
|
520 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
821 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=5 Participants
|
639 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
1001 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
|
Region of Enrollment
Northern Europe
|
252 Participants
n=5 Participants
|
447 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
738 Participants
n=4 Participants
|
|
Region of Enrollment
Southern Europe
|
333 Participants
n=5 Participants
|
712 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
1084 Participants
n=4 Participants
|
|
Creatinine clearance at baseline
<30 milliliter per minute (mL/min)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Creatinine clearance at baseline
30 to < 50 mL/min
|
85 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Creatinine clearance at baseline
50 to < 80 mL/min
|
277 Participants
n=5 Participants
|
510 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
812 Participants
n=4 Participants
|
|
Creatinine clearance at baseline
≥ 80 mL/min
|
168 Participants
n=5 Participants
|
371 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
|
Creatinine clearance at baseline
Missing
|
55 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
CHA2DS2-VASc stroke risk score at baseline
Intermediate risk (score = 1)
|
48 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
177 Participants
n=4 Participants
|
|
CHA2DS2-VASc stroke risk score at baseline
High risk (score >=2)
|
537 Participants
n=5 Participants
|
1033 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
1645 Participants
n=4 Participants
|
|
HAS-BLED bleeding risk score at baseline
Low risk (score < 3)
|
388 Participants
n=5 Participants
|
1031 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
1478 Participants
n=4 Participants
|
|
HAS-BLED bleeding risk score at baseline
High risk (score >=3)
|
197 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Speciality of treating physician
Cardiologist
|
548 Participants
n=5 Participants
|
1087 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
1702 Participants
n=4 Participants
|
|
Speciality of treating physician
General practitioner
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Speciality of treating physician
Other specialist
|
14 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Speciality of treating physician
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Type of hospital or practise
Public
|
207 Participants
n=5 Participants
|
387 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
627 Participants
n=4 Participants
|
|
Type of hospital or practise
Private
|
373 Participants
n=5 Participants
|
753 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
1170 Participants
n=4 Participants
|
|
Type of hospital or practise
Other
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Type of hospital or practise
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Owner of medical practice
Physician or physician group
|
390 Participants
n=5 Participants
|
783 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
1212 Participants
n=4 Participants
|
|
Owner of medical practice
Health Maintenance Organisation
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Owner of medical practice
Community health center
|
24 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Owner of medical practice
Medical / academic health center
|
86 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Owner of medical practice
Other hospital
|
51 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Owner of medical practice
Other health care corporation
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Owner of medical practice
Other
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Owner of medical practice
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).Population: 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.
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).
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
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.
|
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.
|
|---|---|---|---|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
CDS-Baseline
|
63.4 Units on Scale
Standard Deviation 25.2
|
—
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
CDS-Visit 2
|
77.3 Units on Scale
Standard Deviation 19.4
|
—
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
CDS-Visit 3
|
79.2 Units on Scale
Standard Deviation 17.9
|
—
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
SDS-Baseline
|
53.8 Units on Scale
Standard Deviation 16.8
|
—
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
SDS-Visit 2
|
67.7 Units on Scale
Standard Deviation 13.9
|
—
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
SDS-Visit 3
|
70.0 Units on Scale
Standard Deviation 13.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).Population: 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.
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.
Outcome measures
| Measure |
Cohort A Pradaxa®
n=1159 Participants
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).
|
Cohort B VKA
n=78 Participants
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.
|
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.
|
|---|---|---|---|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
CDS-Visit 2
|
78.3 Units on Scale
Standard Deviation 13.4
|
69.1 Units on Scale
Standard Deviation 22.6
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
CDS-Visit 3
|
80.3 Units on Scale
Standard Deviation 10.5
|
69.5 Units on Scale
Standard Deviation 22.3
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
SDS-Visit 2
|
65.9 Units on Scale
Standard Deviation 7.8
|
58.0 Units on Scale
Standard Deviation 13.3
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
SDS-Visit 3
|
68.4 Units on Scale
Standard Deviation 8.8
|
58.8 Units on Scale
Standard Deviation 15.9
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
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).
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
Cohort B VKA
n=1159 Participants
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.
|
Cohort B VKA
n=78 Participants
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.
|
|---|---|---|---|
|
Patient Characterization at Baseline - Categorical Parameters
Age: < 65 years
|
14.2 Percentage of participants
|
17.9 Percentage of participants
|
12.8 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
Age: ≥ 65 and < 75 years
|
36.4 Percentage of participants
|
36.6 Percentage of participants
|
28.2 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
Age: ≥ 75 years
|
49.4 Percentage of participants
|
45.6 Percentage of participants
|
59.0 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
Gender: Male
|
55.9 Percentage of participants
|
55.1 Percentage of participants
|
44.9 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
Gender: Female
|
44.1 Percentage of participants
|
44.9 Percentage of participants
|
55.1 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
MH: Thromboembolism
|
14.0 Percentage of participants
|
9.1 Percentage of participants
|
12.8 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
MH: Cardiovascular Conditions
|
22.4 Percentage of participants
|
18.5 Percentage of participants
|
21.8 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
MH: Bleedings
|
4.1 Percentage of participants
|
2.5 Percentage of participants
|
7.7 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
MH: Other Conditions
|
8.2 Percentage of participants
|
6.4 Percentage of participants
|
9.0 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CoMo: Thromboembolism
|
5.8 Percentage of participants
|
4.0 Percentage of participants
|
9.0 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CoMo: Cardiovascular Conditions
|
79.7 Percentage of participants
|
79.4 Percentage of participants
|
82.1 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CoMo: Bleedings
|
3.6 Percentage of participants
|
2.6 Percentage of participants
|
7.7 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CoMo: Other Conditions
|
21.9 Percentage of participants
|
18.4 Percentage of participants
|
25.6 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Antihypertensives
|
84.8 Percentage of participants
|
81.1 Percentage of participants
|
84.6 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Lipid modifying agents
|
45.3 Percentage of participants
|
42.6 Percentage of participants
|
51.3 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Antiarrhythmic agents
|
29.4 Percentage of participants
|
25.4 Percentage of participants
|
19.2 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Proton pump inhibitors
|
18.8 Percentage of participants
|
15.9 Percentage of participants
|
26.9 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Antithrombotic agents
|
7.4 Percentage of participants
|
10.1 Percentage of participants
|
21.8 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Amiodarone
|
3.9 Percentage of participants
|
5.0 Percentage of participants
|
2.6 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Antidepressants
|
4.4 Percentage of participants
|
4.3 Percentage of participants
|
6.4 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: Verapamil
|
3.6 Percentage of participants
|
2.8 Percentage of participants
|
1.3 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: H2-receptor antagonists
|
2.1 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
CM: NSAIDS
|
0.5 Percentage of participants
|
1.1 Percentage of participants
|
2.6 Percentage of participants
|
|
Patient Characterization at Baseline - Categorical Parameters
DoP: 110 mg twice daily
|
55.9 Percentage of participants
|
57.3 Percentage of participants
|
—
|
|
Patient Characterization at Baseline - Categorical Parameters
DoP: 150 mg twice daily
|
44.1 Percentage of participants
|
42.7 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
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.
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
Cohort B VKA
n=1159 Participants
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.
|
Cohort B VKA
n=78 Participants
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.
|
|---|---|---|---|
|
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
CHA2DS2-VASc
|
3.4 Units on scale
Standard Deviation 1.5
|
3.2 Units on scale
Standard Deviation 1.4
|
3.8 Units on scale
Standard Deviation 1.3
|
|
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
HAS-BLED
|
2.1 Units on scale
Standard Deviation 0.9
|
1.7 Units on scale
Standard Deviation 0.8
|
2.0 Units on scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
Cohort B VKA
n=1159 Participants
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.
|
Cohort B VKA
n=78 Participants
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.
|
|---|---|---|---|
|
Patient Characterization at Baseline - Creatinine Clearance
|
74.40 millilitre/ minute [mL/min]
Standard Deviation 27.08
|
75.89 millilitre/ minute [mL/min]
Standard Deviation 26.60
|
63.83 millilitre/ minute [mL/min]
Standard Deviation 37.55
|
PRIMARY outcome
Timeframe: BaselinePopulation: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
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.
|
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.
|
|---|---|---|---|
|
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
|
4.44 Years
Standard Deviation 3.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).Population: 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.
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).
Outcome measures
| Measure |
Cohort A Pradaxa®
n=585 Participants
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).
|
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.
|
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.
|
|---|---|---|---|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
CDS-Visit 2
|
77.3 Units on Scale
Standard Deviation 19.4
|
—
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
CDS-Visit 3
|
79.2 Units on Scale
Standard Deviation 17.9
|
—
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
SDS-Visit 2
|
67.7 Units on Scale
Standard Deviation 13.9
|
—
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
SDS-Visit 3
|
70.0 Units on Scale
Standard Deviation 13.0
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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).
Outcome measures
| Measure |
Cohort A Pradaxa®
n=1148 Participants
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).
|
Cohort B VKA
n=77 Participants
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.
|
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.
|
|---|---|---|---|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A1
|
3.8 Units on scale
Standard Deviation 0.8
|
3.7 Units on scale
Standard Deviation 0.8
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A2
|
3.1 Units on scale
Standard Deviation 1.2
|
2.8 Units on scale
Standard Deviation 1.2
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A3
|
2.7 Units on scale
Standard Deviation 0.9
|
2.8 Units on scale
Standard Deviation 1.0
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A4
|
4.2 Units on scale
Standard Deviation 0.8
|
3.8 Units on scale
Standard Deviation 1.0
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A5
|
2.8 Units on scale
Standard Deviation 1.4
|
2.9 Units on scale
Standard Deviation 1.4
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A6
|
4.1 Units on scale
Standard Deviation 0.9
|
3.9 Units on scale
Standard Deviation 1.0
|
—
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
A7
|
2.9 Units on scale
Standard Deviation 1.4
|
2.8 Units on scale
Standard Deviation 1.5
|
—
|
Adverse Events
Cohort A Pradaxa®
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Cohort B Pradaxa®
Serious events: 8 serious events
Other events: 0 other events
Deaths: 5 deaths
Cohort B VKA
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A Pradaxa®
n=585 participants at risk
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).
|
Cohort B Pradaxa®
n=1159 participants at risk
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).
|
Cohort B VKA
n=78 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Cardiac disorders
Cardiac failure
|
0.17%
1/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.17%
1/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Infections and infestations
Septic shock
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
1/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
1/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
1.3%
1/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
1.3%
1/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/585 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.09%
1/1159 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
0.00%
0/78 • From signing the informed consent till end of the study; up to 290 days
In this non-interventional study the analysis of Adverse Events (AE) was based on collected serious or non-serious Adverse Drug Reactions (ADR) and fatal Adverse Events for eligible patients only.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER