Trial Outcomes & Findings for Patient Convenience Study- NIS RELATE (NCT NCT02849509)

NCT ID: NCT02849509

Last Updated: 2019-07-08

Results Overview

Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.

• Recruitment status: COMPLETED
• Target enrollment: 1313 participants
• Primary outcome timeframe: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
• Results posted on: 2019-07-08

Participant Flow

Participant milestones

Measure	Cohort A (Switch Patients - Pradaxa) Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - Pradaxa) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
Overall Study STARTED	379	591	343
Overall Study COMPLETED	289	425	258
Overall Study NOT COMPLETED	90	166	85

Reasons for withdrawal

Measure	Cohort A (Switch Patients - Pradaxa) Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - Pradaxa) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 disease under study	1	1	1
Overall Study Worsening of other pre-existing disease	0	1	2
Overall Study Other adverse event	36	41	8
Overall Study Withdrawal by Subject	6	17	12
Overall Study Lost to Follow-up	27	67	36
Overall Study Other, reason not specified	14	29	25
Overall Study No inform. on termination of Pradaxa/VKA	6	10	1

Baseline Characteristics

The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

Baseline characteristics by cohort

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - Pradaxa) n=591 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Total n=1313 Participants Total of all reporting groups
Age, Continuous	69.7 Years STANDARD_DEVIATION 9.0 • n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	67.3 Years STANDARD_DEVIATION 9.8 • n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	63.4 Years STANDARD_DEVIATION 10.9 • n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	67.0 Years STANDARD_DEVIATION 10.2 • n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Age, Customized < 65 Years	95 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	196 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	184 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	475 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Age, Customized >= 65 and < 75 Year	154 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	256 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	101 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	511 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Age, Customized >= 75 Years	130 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	139 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	58 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	327 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Sex: Female, Male Female	130 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	228 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	106 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	464 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Sex: Female, Male Male	249 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	363 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	237 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	849 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Korea, Republic Of · Non-South Korea	54 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	124 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	32 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	210 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Region of Enrollment Korea, Republic Of · South Korea	325 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	467 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	311 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	1103 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Type of hospital or practice Public	171 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	255 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	133 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	559 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Type of hospital or practice Private	200 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	309 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	201 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	710 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Type of hospital or practice Other	8 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	27 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	9 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	44 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Physician or physician group	174 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	268 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	162 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	604 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Health Maintenance Organisation (HMO)	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Community health center	3 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	5 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	2 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	10 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Medical / academic health center	156 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	231 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	144 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	531 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Other hospital	22 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	43 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	35 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	100 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Other health care corporation	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Owner of medical practice Other	24 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	44 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	68 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Speciality of treating physician Cardiologist	362 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	572 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	323 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	1257 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Speciality of treating physician General practitioner	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	3 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	1 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	4 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Speciality of treating physician Other specialist	17 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	16 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	19 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	52 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
Baseline creatinine clearance category <30 mL/min	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	0 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	13 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	13 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Baseline creatinine clearance category 30 to <50 mL/min	64 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	66 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	29 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	159 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Baseline creatinine clearance category 50 to <80 mL/min	126 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	210 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	78 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	414 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Baseline creatinine clearance category >=80 mL/min	69 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	140 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	69 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	278 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
Baseline creatinine clearance category Missing	120 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	175 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	154 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries	449 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries
CHA2DS2-VASc score Low risk (score=0)	5 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	29 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	50 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	84 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
CHA2DS2-VASc score Intermediate risk (score=1)	43 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	78 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	106 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	227 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
CHA2DS2-VASc score High risk (score ≥2)	331 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	482 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	187 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	1000 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
CHA2DS2-VASc score Missing	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	2 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	2 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
HAS-BLED score Low risk (score <3)	291 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	540 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	306 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	1137 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
HAS-BLED score High risk (score ≥3)	88 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	49 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	37 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	174 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.
HAS-BLED score Missing	0 Participants n=379 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	2 Participants n=591 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	0 Participants n=343 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.	2 Participants n=1313 Participants • The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

PRIMARY outcome

Timeframe: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.

PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment Convenience dimension score: Baseline	71.4 Unit on scale Standard Deviation 21.8	—	—
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment Convenience dimension score: Second assessment	79.6 Unit on scale Standard Deviation 18.1	—	—
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment Satisfaction dimension score: Baseline	61.0 Unit on scale Standard Deviation 13.3	—	—
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment Satisfaction dimension score: Second assessment	63.2 Unit on scale Standard Deviation 14.6	—	—

PRIMARY outcome

Timeframe: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable.

PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 Baseline Assessment Convenience dimension score: Last assessment	82.0 Unit on scale Standard Deviation 16.8	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment Convenience dimension score: Baseline	71.4 Unit on scale Standard Deviation 21.8	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment Satisfaction dimension score: Baseline	61.0 Unit on scale Standard Deviation 13.3	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment Satisfaction dimension score: Last assessment	64.4 Unit on scale Standard Deviation 14.7	—	—

PRIMARY outcome

Timeframe: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.

Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.

Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.

PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=591 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 Assessment Compared Between Treatment Groups Convenience dimension score	78.4 Unit on scale Standard Deviation 14.6	75.1 Unit on scale Standard Deviation 19.6	—
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups Satisfaction dimension score	61.5 Unit on scale Standard Deviation 12.7	59.9 Unit on scale Standard Deviation 13.5	—

PRIMARY outcome

Timeframe: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.

Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.

Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.

Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=591 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 Last Assessment Compared Between Treatment Groups Convenience dimension score	80.4 Unit on scale Standard Deviation 13.6	76.0 Unit on scale Standard Deviation 18.9	—
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups Satisfaction dimension score	63.9 Unit on scale Standard Deviation 11.6	60.9 Unit on scale Standard Deviation 12.8	—

PRIMARY outcome

Timeframe: Baseline (Visit1)

Population: Eligible patients who took the prescribed treatment and without an important protocol violation

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

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=591 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 DoP:110 mg twice daily	68.1 Percentage of participant	58.0 Percentage of participant	—
Patient Characterization at Baseline - Categorical Parameters < 65 Years	25.1 Percentage of participant	33.2 Percentage of participant	53.6 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters >= 65 and < 75 Years	40.6 Percentage of participant	43.3 Percentage of participant	29.4 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters >= 75 Years	34.3 Percentage of participant	23.5 Percentage of participant	16.9 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters Female	34.3 Percentage of participant	38.6 Percentage of participant	30.9 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters Male	65.7 Percentage of participant	61.4 Percentage of participant	69.1 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters MH: Thromboembolism	6.3 Percentage of participant	3.4 Percentage of participant	1.5 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters MH: Cardiovascular Conditions	7.7 Percentage of participant	5.1 Percentage of participant	4.4 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters MH: Bleedings	2.6 Percentage of participant	1.0 Percentage of participant	0.9 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters MH: Other Conditions	5.8 Percentage of participant	3.7 Percentage of participant	3.8 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CoMo: Thromboembolism	9.8 Percentage of participant	4.7 Percentage of participant	7.6 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CoMo: Cardiovascular Conditions	64.1 Percentage of participant	50.9 Percentage of participant	40.5 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CoMo: Bleedings	2.4 Percentage of participant	2.5 Percentage of participant	2.3 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CoMo: Other Conditions	26.9 Percentage of participant	20.8 Percentage of participant	17.8 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Antihypertensives	67.5 Percentage of participant	56.0 Percentage of participant	47.8 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Lipid modifying agents	46.7 Percentage of participant	33.5 Percentage of participant	28.0 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Antithrombotic agents	15.3 Percentage of participant	9.5 Percentage of participant	19.8 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Proton pump inhibitors	16.4 Percentage of participant	13.9 Percentage of participant	7.9 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Amiodarone	7.4 Percentage of participant	7.1 Percentage of participant	5.8 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:H2-receptor antagonists	8.7 Percentage of participant	7.1 Percentage of participant	2.0 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:NSAIDS	1.8 Percentage of participant	2.9 Percentage of participant	1.7 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters CM:Verapamil	1.1 Percentage of participant	1.5 Percentage of participant	1.7 Percentage of participant
Patient Characterization at Baseline - Categorical Parameters DoP:150 mg twice daily	31.9 Percentage of participant	42.0 Percentage of participant	—

PRIMARY outcome

Timeframe: Baseline (Visit1)

Population: Eligible patients who took the prescribed treatment and without an important protocol violation

Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 - Duration of Previous VKA Treatment for Cohort A	4.28 Years Standard Deviation 3.63	—	—

SECONDARY outcome

Timeframe: Baseline (Visit1)

Population: Eligible patients who took the prescribed treatment and without an important protocol violation

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.

CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=589 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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	3.1 unit on scale Standard Deviation 1.4	2.6 unit on scale Standard Deviation 1.4	2.0 unit on scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline (Visit1)

Population: Eligible patients who took the prescribed treatment and without an important protocol violation

HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol.

HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=589 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) n=343 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 - HAS-BLED Bleeding Risk Score	1.8 unit on scale Standard Deviation 1.1	1.3 unit on scale Standard Deviation 0.9	1.1 unit on scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline (Visit1)

Population: Eligible patients who took the prescribed treatment and without an important protocol violation

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 (Switch Patients - Pradaxa) n=259 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=416 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) n=189 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 - Creatinine Clearance	68.114 mL/min Standard Deviation 23.147	75.367 mL/min Standard Deviation 29.028	73.017 mL/min Standard Deviation 29.179

SECONDARY outcome

Timeframe: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.

The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).

The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score.

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=379 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were 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 Convenience dimension score (Visit 2)	79.6 Unit on scale Standard Deviation 18.1	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment Convenience dimension score (Visit 3)	82.0 Unit on scale Standard Deviation 16.8	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment Satisfaction dimension score (Visit 2)	63.2 Unit on scale Standard Deviation 14.6	—	—
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment Satisfaction dimension score (Visit 3)	64.4 Unit on scale Standard Deviation 14.7	—	—

SECONDARY outcome

Timeframe: Baseline (Visit1)

Population: The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. PACT-Q1 data which were collected after the first dose or using incorrect procedure were excluded from the summary.

For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.

The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.

The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).

Outcome measures

Measure	Cohort A (Switch Patients - Pradaxa) n=580 Participants Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - VKA) n=340 Participants Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.	Cohort B (New Patients - VKA) Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A1 - Confidence in prevention of blood clots	3.4 Unit on scale Standard Deviation 1.0	3.3 Unit on scale Standard Deviation 1.0	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A2 - Expectations of symptom relief	3.4 Unit on scale Standard Deviation 0.9	3.3 Unit on scale Standard Deviation 1.0	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A3 - Expectations of side effects	2.5 Unit on scale Standard Deviation 1.0	2.6 Unit on scale Standard Deviation 1.0	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A4 - Importance of ease of use	3.7 Unit on scale Standard Deviation 0.9	3.5 Unit on scale Standard Deviation 1.0	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A5 - Worries about making mistakes	2.5 Unit on scale Standard Deviation 1.2	2.5 Unit on scale Standard Deviation 1.2	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A6 - Importance of independency	3.7 Unit on scale Standard Deviation 0.9	3.7 Unit on scale Standard Deviation 1.0	—
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B A7 - Worries about cost	2.7 Unit on scale Standard Deviation 1.2	2.6 Unit on scale Standard Deviation 1.2	—

Adverse Events

Cohort A (Switch Patients - Pradaxa)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Cohort B (New Patients - Pradaxa)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B (New Patients - VKA)

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A (Switch Patients - Pradaxa) n=379 participants at risk Patients with non-valvular atrial fibrillation (NVAF), who were treated with a Vitamin K Antagonist (VKA) therapy for at least 3 months for stroke prevention and then switched to 110 or 150 milligram (mg) twice daily dose of Pradaxa.	Cohort B (New Patients - Pradaxa) n=591 participants at risk Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on 110 or 150 mg twice daily Pradaxa	Cohort B (New Patients - VKA) n=343 participants at risk Newly diagnosed NVAF patients who were not previously treated with an anticoagulant for the prevention of stroke, and were initiated on VKA therapy. The choice of vitamin K antagonist and the appropriate dosing was at the discretion of the physician.
Investigations International normalised ratio increased	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.58% 2/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Cardiac disorders Acute myocardial infarction	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.29% 1/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Gastrointestinal disorders Gastrointestinal haemorrhage	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Gastrointestinal disorders Melaena	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.17% 1/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
General disorders Multiple organ dysfunction syndrome	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Injury, poisoning and procedural complications Overdose	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.29% 1/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Metabolism and nutrition disorders Metabolic acidosis	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Nervous system disorders Cerebral infarction	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.29% 1/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Nervous system disorders Cerebrovascular accident	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Renal and urinary disorders Haematuria	0.00% 0/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.29% 1/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal
Vascular disorders Hypovolaemic shock	0.26% 1/379 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/591 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal	0.00% 0/343 • From the first administration of study medication until end of the study, up to 406 days In this non-interventional study, a systematic collection of safety data was neither planned nor performed. The focus was on non-serious and serious adverse drug reactions to Pradaxa® and VKA and on fatal adverse events (AEs), that is, AEs that were not considered to have a reasonable possibility to be causally related to the prescribed anticoagulant treatment were only collected when fatal

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place