Trial Outcomes & Findings for Anticoagulants Comparative Benefit-risk Ratio in Real Life (NCT NCT02785354)
NCT ID: NCT02785354
Last Updated: 2018-11-02
Results Overview
First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
Recruitment status
COMPLETED
Target enrollment
103101 participants
Primary outcome timeframe
One year
Results posted on
2018-11-02
Participant Flow
The study ENGEL 2 is a real-world historical cohort study in the French nationwide healthcare claims and hospitalization database (SNIIRAM) including new users of DOAC or VKA for nonvalvular atrial fibrillation (NVAF) in 2013 with a follow-up for one year (main objective).
The main objective was to compare the risk \& effectiveness for dabigatran vs VKA, \& for rivaroxaban vs VKA. The main analysis was done for hdPS matched patients (pts.) with atrial fibrillation (AF) diagnosis information in the database.
Participant milestones
| Measure |
Dabigatran
Patients with a first dispensing of dabigatran in 2013 for NVAF.
|
Rivaroxaban
Patients with a first dispensing of rivaroxaban in 2013 for NVAF.
|
Vitamin K Antagonists
Patients with a first dispensing of VKA in 2013 for NVAF.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27060
|
31388
|
44653
|
|
Overall Study
COMPLETED
|
27060
|
31388
|
44653
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
Baseline characteristics by cohort
| Measure |
Dabigatran
n=27060 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban
n=31388 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Vitamin K Antagonists
n=44653 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Total
n=103101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex/Gender, Customized
Dabigatran vs VKA (matched pop) · Male
|
11164 Participants
n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
—
|
11164 Participants
n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
22328 Participants
n=40978 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Age, Customized
Overall
|
73.2 Years
STANDARD_DEVIATION 11.8 • n=27060 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
73.2 Years
STANDARD_DEVIATION 11.8 • n=31388 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
77.9 Years
STANDARD_DEVIATION 11.1 • n=44653 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
75.2 Years
STANDARD_DEVIATION 11.7 • n=103101 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Age, Customized
Dabigatran vs VKA (matched pop)
|
75.3 Years
STANDARD_DEVIATION 10.7 • n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
—
|
75.4 Years
STANDARD_DEVIATION 10.7 • n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
75.4 Years
STANDARD_DEVIATION 10.7 • n=40978 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Age, Customized
Rivaroxaban vs VKA (matched pop)
|
—
|
75.3 Years
STANDARD_DEVIATION 10.7 • n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
75.4 Years
STANDARD_DEVIATION 10.7 • n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
75.4 Years
STANDARD_DEVIATION 10.7 • n=46106 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Sex/Gender, Customized
Overall · Male
|
15253 Participants
n=27060 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
17653 Participants
n=31388 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
22868 Participants
n=44653 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
55774 Participants
n=103101 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Sex/Gender, Customized
Overall · Female
|
11807 Participants
n=27060 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
13735 Participants
n=31388 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
21785 Participants
n=44653 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
47327 Participants
n=103101 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Sex/Gender, Customized
Dabigatran vs VKA (matched pop) · Female
|
9325 Participants
n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
—
|
9325 Participants
n=20489 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
18650 Participants
n=40978 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Sex/Gender, Customized
Rivaroxaban vs VKA (matched pop) · Male
|
—
|
12557 Participants
n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
12557 Participants
n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
25114 Participants
n=46106 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
|
Sex/Gender, Customized
Rivaroxaban vs VKA (matched pop) · Female
|
—
|
10496 Participants
n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
10496 Participants
n=23053 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
20992 Participants
n=46106 Participants • The main analysis was on matched patients 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and hdPS (± 0.05).Baseline measures were presented for overall treatment groups and matched populations: dabigatran vs VKA and rivaroxaban vs VKA.
|
PRIMARY outcome
Timeframe: One yearPopulation: Patients (pts) with a first dispensing (dispen.) of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks (wks.)), gender, age at index date (± 1 year (yr)) and high-dimensional propensity score (hdPS, ± 0.05).
First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype).
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Clinically Relevant Bleeding
|
367 participants with event
Interval 2.2 to 2.7
|
668 participants with event
Interval 4.1 to 4.8
|
635 participants with event
Interval 3.5 to 4.1
|
767 participants with event
Interval 4.2 to 4.8
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Hemorrhagic stroke, 2. Other critical organ or site bleeding, 3. Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay.
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Major Bleeding
|
178 participants with events
Interval 1.0 to 1.4
|
341 participants with events
Interval 2.0 to 2.5
|
280 participants with events
Interval 1.5 to 1.9
|
417 participants with events
Interval 2.2 to 2.7
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Ischemic or undefined stroke, 2. Systemic arterial embolism.
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Arterial Thrombotic Event
|
226 participants with events
Interval 1.4 to 1.8
|
321 participants with events
Interval 1.9 to 2.4
|
343 participants with events
Interval 1.8 to 2.2
|
351 participants with events
Interval 1.9 to 2.3
|
PRIMARY outcome
Timeframe: One yearPopulation: Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
First hospitalization with primary diagnosis (ICD-10 codes) of: 1. Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)), 2. Unstable angina.
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Acute Coronary Syndrome
|
176 participants with events
Interval 1.1 to 1.4
|
238 participants with events
Interval 1.4 to 1.8
|
230 participants with events
Interval 1.2 to 1.5
|
277 participants with events
Interval 1.4 to 1.8
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
All-cause death (cause of death not available in the database).
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Death (All-cause)
|
686 participants with events
Interval 4.6 to 5.3
|
983 participants with events
Interval 6.4 to 7.3
|
908 participants with events
Interval 5.2 to 6.0
|
1186 participants with events
Interval 6.9 to 7.8
|
PRIMARY outcome
Timeframe: One yearPopulation: Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).
First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.
Outcome measures
| Measure |
Dabigatran (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of dabigatran in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Dabigatran vs VKA)
n=20489 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
Rivaroxaban (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of rivaroxaban in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
VKA (Rivaroxaban vs VKA)
n=23053 Participants
Patients with a first dispensing of VKA in 2013 for NVAF, matched 1:1 on the date of the first dispensing, gender, age at index date, and hdPS.
|
|---|---|---|---|---|
|
Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)
|
1340 participants with events
Interval 8.8 to 9.8
|
1970 participants with events
Interval 12.5 to 13.7
|
1967 participants with events
Interval 11.1 to 12.1
|
2328 participants with events
Interval 13.2 to 14.3
|
Adverse Events
Dabigatran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rivaroxaban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin K Antagonists
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
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