Trial Outcomes & Findings for RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism (NCT NCT02596230)
NCT ID: NCT02596230
Last Updated: 2020-04-29
Results Overview
Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.
Recruitment status
COMPLETED
Target enrollment
7797 participants
Primary outcome timeframe
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Results posted on
2020-04-29
Participant Flow
This study characterizes patients following acute venous thromboembolism and assesses the safety and effectiveness of dabigatran etexilate in the treatment and secondary prevention of acute DVT and PE in comparison to vitamin K antagonist in routine clinical practice. This is a large multi-center observational study based on new data collection.
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they met all inclusion/exclusion criteria. The study enrolled and characterized all patients within 30 days after being diagnosed with an acute DVT and/or PE.
Participant milestones
| Measure |
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
|
Dabigatran Etexilate (1)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
|
Dabigatran Etexilate (2)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
|
Vitamin K Antagonist (1)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
|
Vitamin K Antagonist (2)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
|
|---|---|---|---|---|---|
|
Objective 1, One Visit During 14 Days
STARTED
|
3714
|
1006
|
0
|
1375
|
0
|
|
Objective 1, One Visit During 14 Days
COMPLETED
|
3714
|
1006
|
0
|
1375
|
0
|
|
Objective 1, One Visit During 14 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period for Objective 2
STARTED
|
3714
|
1006
|
910
|
1375
|
792
|
|
Screening Period for Objective 2
COMPLETED
|
0
|
778
|
910
|
529
|
792
|
|
Screening Period for Objective 2
NOT COMPLETED
|
3714
|
228
|
0
|
846
|
0
|
|
Objective 2, One Year
STARTED
|
0
|
778
|
910
|
529
|
792
|
|
Objective 2, One Year
COMPLETED
|
0
|
710
|
812
|
471
|
714
|
|
Objective 2, One Year
NOT COMPLETED
|
0
|
68
|
98
|
58
|
78
|
Reasons for withdrawal
| Measure |
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
|
Dabigatran Etexilate (1)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
|
Dabigatran Etexilate (2)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
|
Vitamin K Antagonist (1)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
|
Vitamin K Antagonist (2)
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
|
|---|---|---|---|---|---|
|
Screening Period for Objective 2
Participants not participating in obj 2
|
3714
|
228
|
0
|
846
|
0
|
|
Objective 2, One Year
Lost to Follow-up
|
0
|
41
|
41
|
32
|
46
|
|
Objective 2, One Year
Withdrawal by Subject
|
0
|
11
|
14
|
5
|
2
|
|
Objective 2, One Year
Adverse drug reaction
|
0
|
1
|
0
|
0
|
0
|
|
Objective 2, One Year
Death
|
0
|
12
|
41
|
21
|
30
|
|
Objective 2, One Year
Other
|
0
|
3
|
2
|
0
|
0
|
Baseline Characteristics
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
Baseline characteristics by cohort
| Measure |
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist
n=3714 Participants
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
|
Dabigatran Etexilate (1)
n=1006 Participants
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
|
Dabigatran Etexilate (2)
n=910 Participants
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
|
Vitamin K Antagonist (1)
n=1375 Participants
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
|
Vitamin K Antagonist (2)
n=792 Participants
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
|
Total
n=7797 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
58.4 Years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 16.6 • n=4 Participants
|
59.0 Years
STANDARD_DEVIATION 16.6 • n=21 Participants
|
60.9 Years
STANDARD_DEVIATION 17.0 • n=8 Participants
|
|
Sex/Gender, Customized
Male
|
1806 Participants
n=5 Participants
|
548 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
708 Participants
n=4 Participants
|
417 Participants
n=21 Participants
|
3956 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Female
|
1907 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
667 Participants
n=4 Participants
|
375 Participants
n=21 Participants
|
3840 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
420 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
936 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
111 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
209 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2620 Participants
n=5 Participants
|
828 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
1152 Participants
n=4 Participants
|
600 Participants
n=21 Participants
|
5942 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
552 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
621 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population
Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=6095 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 1: Age
|
61.5 years
Standard Deviation 17.0
|
—
|
PRIMARY outcome
Timeframe: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.
Sex of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=6095 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 1: Sex
Missing data · Participants
|
1 Participants
|
—
|
|
Objective 1: Sex
Male · Participants
|
3062 Participants
|
—
|
|
Objective 1: Sex
Female · Participants
|
3032 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.
Type of index event (e.g., DVT or PE or DVT and PE) diagnosed at the time of acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=6095 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 1: Index Event
DVT · Participants
|
3644 Participants
|
—
|
|
Objective 1: Index Event
PE · Participants
|
1588 Participants
|
—
|
|
Objective 1: Index Event
DVT and PE · Participants
|
863 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.
Type of treatment received following acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen. The arm presented in this endpoint was separated into three arms in the participant flow tables ("Not assigned to Dabigatran etexilate or Vitamin K antagonist","Dabigatran etexilate (1)" and "Vitamin K antagonist (1)") in order to distinguish patients participating in both objectives from patients only in objective 2.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=6095 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 1: Anticoagulant Treatment
Dabigatran · Participants
|
947 Participants
|
—
|
|
Objective 1: Anticoagulant Treatment
vitamin K antagonist (VKA) · Participants
|
1388 Participants
|
—
|
|
Objective 1: Anticoagulant Treatment
Edoxaban · Participants
|
103 Participants
|
—
|
|
Objective 1: Anticoagulant Treatment
Rivaroxaban · Participants
|
1558 Participants
|
—
|
|
Objective 1: Anticoagulant Treatment
Apixaban · Participants
|
686 Participants
|
—
|
|
Objective 1: Anticoagulant Treatment
Other · Participants
|
1413 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap and who took the prescribed treatment at least once.
Incidence rate of ISTH (International Society on Thrombosis and Haemostasis) major bleeding and CRNMB (clinically relevant non major bleeding) per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=1681 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
n=1288 Participants
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs)
|
2.63 events per 100 patient-years
Interval 1.79 to 3.73
|
4.42 events per 100 patient-years
Interval 3.18 to 5.97
|
PRIMARY outcome
Timeframe: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.
Incidence rate of Symptomatic Recurrent VTE (Venous Thromboembolism) including VTE related mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=1681 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
n=1288 Participants
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
|
1.53 events per 100 patient-years
Interval 0.91 to 2.42
|
2.01 events per 100 patient-years
Interval 1.21 to 3.14
|
SECONDARY outcome
Timeframe: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.
Incidence rate of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=1681 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
n=1288 Participants
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 2: Incidence Rate of Recurrent DVT and/or PE
|
1.61 events per 100 patient-years
Interval 0.97 to 2.52
|
2.22 events per 100 patient-years
Interval 1.38 to 3.4
|
SECONDARY outcome
Timeframe: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.
Incidence rate of VTE-related Mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=1681 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
n=1288 Participants
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 2: Incidence Rate of VTE-related Mortality
|
0 events per 100 patient-years
Interval 0.0 to 0.0
|
0.42 events per 100 patient-years
Interval 0.11 to 1.08
|
SECONDARY outcome
Timeframe: 12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Population: Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.
Incidence rate of all-cause mortality per 100 patient-years (1/(100\*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model. For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation.
Outcome measures
| Measure |
All Participants With a DVT and/or PE
n=1681 Participants
All participants diagnosed with Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE).
|
Vitamin K Antagonist
n=1288 Participants
Participants diagnosed with an acute DVT and/or PE and treated with Vitamin K antagonist. This includes both participants who participated in objective 1 and 2 and new participants only participating in objective 2.
|
|---|---|---|
|
Objective 2: Incidence Rate of All-cause Mortality
|
2.12 events per 100 patient-years
Interval 1.37 to 3.12
|
3.06 events per 100 patient-years
Interval 2.05 to 4.39
|
Adverse Events
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist
Serious events: 60 serious events
Other events: 0 other events
Deaths: 54 deaths
Dabigatran Etexilate (1)
Serious events: 22 serious events
Other events: 0 other events
Deaths: 13 deaths
Dabigatran Etexilate (2)
Serious events: 47 serious events
Other events: 0 other events
Deaths: 42 deaths
Vitamin K Antagonist (1)
Serious events: 34 serious events
Other events: 0 other events
Deaths: 25 deaths
Vitamin K Antagonist (2)
Serious events: 41 serious events
Other events: 0 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Not Assigned to Dabigatran Etexilate or Vitamin K Antagonist
n=3714 participants at risk
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with either Edoxaban, Rivaroxaban, Apixaban or other anticoagulation treatments. Participants analyzed for objective 1 only.
|
Dabigatran Etexilate (1)
n=1006 participants at risk
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. Participants analyzed for objective 1 or for objective 1 and 2.
|
Dabigatran Etexilate (2)
n=910 participants at risk
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Dabigatran etexilate. New participants analyzed for objective 2 only.
|
Vitamin K Antagonist (1)
n=1375 participants at risk
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. Participants analyzed for objective 1 or for objective 1 and 2.
|
Vitamin K Antagonist (2)
n=792 participants at risk
Participants diagnosed with an acute Deep Vein Thrombosis (DVT) irrespective of location and/or Pulmonary Embolism (PE) and treated with Vitamin K antagonist. New participants analyzed for objective 2 only.
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Arterial rupture
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
5/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.55%
5/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.15%
2/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.44%
4/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.15%
2/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiogenic shock
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.15%
2/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Congenital, familial and genetic disorders
Right-to-left cardiac shunt
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
3/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.25%
2/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Catheter site haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Death
|
0.19%
7/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.30%
3/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.66%
6/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.51%
7/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.88%
7/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Drug intolerance
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
General disorders
Sudden death
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Infections and infestations
Pneumonia
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.25%
2/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Infections and infestations
Sepsis
|
0.08%
3/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.15%
2/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Infections and infestations
Septic shock
|
0.08%
3/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Investigations
Blood urine present
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.22%
2/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.25%
2/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular cancer metastatic
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Cerebellar haematoma
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Coma
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.20%
2/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Renal and urinary disorders
Nephroptosis
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Renal and urinary disorders
Renal failure
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.15%
2/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.05%
2/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.25%
2/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
5/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.22%
3/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.33%
3/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.25%
2/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.10%
1/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Haematoma
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.07%
1/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.13%
1/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Internal haemorrhage
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.11%
1/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Vascular disorders
Peripheral ischaemia
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3714 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1006 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/910 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/1375 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
0.00%
0/792 • From the time of VTE until the end of the study (Dabigatran etexilate (1) and (2) and Vitamin K antagonist (1) and (2)) or from the time of informed consent until the end of the study (not assigned to Dabigatran etexilate or Vitamin K antagonist), up to 12 months.
Adverse events are reported based on all eligible patients.
|
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
- Publication restrictions are in place